2006

November 2006

1st November 2006 - 3rd November 2006 at the Westin Horton Plaza in San Diego, CA, USA [927]
5th Annual Electronic Submissions Conference - eCTDs: Entering the Mainstream
In response to a growing demand for a comprehensive electronic submission conference, this year’s conference will be expanded to multiple tracks. As more and more companies gain experience or contemplate the transition to electronic submissions, and as the electronic submission environment changes, it is imperative that the stakeholders (agency, industry and service providers) maintain open communication regarding new regulations, guidance, and the experience of the implementation. This conference will focus on how to optimize the experience if you are just getting started, lessons learned for the experienced and more advanced, and how converging electronic standards and formats drive the future vision (5-year horizon) of interactions between the life sciences industry, regulators, and the public.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11208/06030.pdf

2nd November 2006 - 3rd November 2006 at the Westin Horton Plaza in San Diego, CA, USA [854]
4th Annual Electronic Submissions Conference - eCTDs: Entering the Mainstream
In response to a growing demand for a comprehensive electronic submission conference, this year’s conference will be expanded to multiple tracks. As more and more companies gain experience or contemplate the transition to electronic submissions, and as the electronic submission environment changes, it is imperative that the stakeholders (agency, industry and service providers) maintain open communication regarding new regulations, guidance, and the experience of the implementation. This conference will focus on how to optimize the experience if you are just getting started, lessons learned for the experienced and more advanced, and how converging electronic standards and formats drive the future vision (5-year horizon) of interactions between the life sciences industry, regulators, and the public.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11208/06030.pdf

2nd November 2006 - 3rd November 2006 at the Hotel Sofitel Paris Forum Rive Gauche in Paris, France [853]
DIA Pharmacovigilance WorkShop on: Safe Studies Throughout the Life Cycle - A Cradle to Grave Approach
The scrutiny and pressure on the pharmaceutical sector to deliver safe medicines has never been so great as it is now. This pressure comes from all directions: both enhanced compliance with more regulation and yet a demand for value for money from both governments and patients. This is against a backdrop of accusations of misconduct about financial inducement to change prescribing practices and encourage off label use. It is now urgent for the pharmaceutical sector to consider and explore how closer and active collaboration between stakeholders in marketed products may produce the best evidence so that we can deliver society’s Expectations about safety and effectiveness. Ideally, decisions about benefit-risk should be informed by patients’ outcomes in the real world.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11071/06113.pdf

2nd November 2006 - 3rd November 2006 at the Venue: The Rembrandt Hotel in London, UK [969]
CONDUCTING PRE AND POST MARKET MEDICAL DEVICE CLINICAL STUDIES
This course has been designed specifically for those involved in pre and post market studies wtihin the medical device industry. The device development process can be complex, costly and can take years to complete. The collection of clinical data to demonstrate safety and performance of a device is pivotal to the development process and necessary for regulatory approval. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market. This course willl cover the full range of clinical research activities taht should be applied during the collection of data for both pre- and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe. Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe. There will be ample time for case studies and group discussions.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=526

5th November 2006 - 8th November 2006 at the Congress Center in Basel, Switzerland [855]
DIA Multi-Track Conference on CDM, eClinical & Clinical Research "The Changing World of Clinical Trials
The clinical trials process is undergoing a technology revolution. Our roles in support of clinical trials, be it investigator, study manager, monitor or data manager, are changing. Is technology driving the practice or do new clinical processes sufficiently influence the development and adoption of electronic submission? This conference is designed to address these issues by providing a unique forum that brings all clinical development professionals together. The Multi-Track format of this event will facilitate refreshing debate amongst all parties involved with clinical trials from the Investigator Site to database closure. We welcome your support.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/10452/call%20for%20abstract%2006109.pdf

5th November 2006 - 8th November 2006 at the Congress Center in Basel, Switzerland [928]
The Changing World of Clinical Trials - European Clinical Research Conference, European eClinical Conference, 16th Annual European CDM Conference
The clinical trials process is undergoing a technology revolution. Our roles in support of clinical trials, be it investigator, study manager, monitor or data manager, are changing. Is technology driving the practice or do new clinical processes sufficiently influence the development and adoption of electronic submission? This conference is designed to address these issues by providing a unique forum that brings all clinical development professionals together. the Multi-Track format of this event will facilitate refreshing debate amongst all parties involved with clinical trials from the Investigator Site do database closure. We welcome your support.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/10452/call%20for%20abstract%2006109.pdf

6th November 2006 - 7th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [934]
A Critical Path Approach to Rapid Diagnostics Development and Infectious Disease Treatment
The rapid diagnosis of infectious disease has never been more important or relevant. In addition to urgent medical and public health needs posed by emerging infectious diseases (SARS, avian influenza) and bioterrorism, more rapid and accurate diagnosis of infectious diseases can lead to targeted and more efficient treatments with improved outcomes. The concept of matching a therapeutic entity with diagnostic testing, can ensure the right drug, at the right level, for the right indication, for the right patient, at the right time. Application of new technology for diagnostic uses offers tremendous potential for changing practice paradigms. New methods in molecular diagnosis, new information on genomics, proteomics and the biologic basis of infection, along with improvements in portability, robustness, and connectivity have made diagnostic windows possible that would not have even been considered before. Integrating and coordinating multiple facets of today’s healthcare system has been slow and is the fundamental challenge for change. This workshop focuses on approaches to shorten the critical path in new product development and integrating new technology into clinical practice. It will also focus on transitioning new diagnostic tests from the research bench to the laboratory and near-patient settings.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11361/06033.pdf

6th November 2006 - 8th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [970]
PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA - Brazil, Peru, Ecuador, Mexico, Argentina, Chile, Venezuela, Colombia, Central America
Day 1: Brazil - Peru - Ecuador Day 2: Mexico - Argentina - Chile - Venezuela Day 3: Colombia - Central America - Harmonisation Efforts in Latin America This seminar will provide up-to-date coverage of the requirements that underpin a successful pharmaceutical and cosmetic products marketing authorisation application across Latin America. In a carefully structured programme, speakers will cover the official regulatory sources but will also share the interpretation and alternatives to local/specific legal requirements that only people with hands on experience in the region can provide. The seminar will also include an overview of the regulatory aspects of: site inspection, clinical trials, package labelling and the requirements for the marketing of Generic drugs, OTC medicines and Diagnostic kits. By the end of the seminar, during the interactive workshop, the participants will be invited to put learning into practice through the resolution of case studies. It is anticipated that the seminar will be useful both as an inventory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=325

7th November 2006 - 10th November 2006 at the Hall 2-7 Beijing China International Exhibition Center in Beijing, China [697]
The 11th China International Pharmaceutical Industry Exhibition
The 11th Anniversary Ceremony of China International Pharmaceutical Industry Exhibition (China-Pharm) will be held in Beijing, China, in the autumn of 2005. Since its debut in 1996, the actual exhibition area of CHINA-PHARM keeps increasing by 20% at each event, the actual amount of transaction at each event is also increasing year by year. And the number of visitors/time reaching nearly 40,000. Exhibition Scope?? Medicine Machinery and equipment for pharmaceutical raw materials Preparation machinery Pharmaceutical milling machinery Slicing machinery for herbal medicine Water treatment equipment for pharmaceutical use Pharmaceutical packaging machinery Medicine testing instruments Other pharmaceutical machinery and equipment on-spot cleaning & sterilizing equipment, Packaging material Service Publication Analytical instruments life science instruments, instruments for environmental protection, laboratory equipment, food analysis instruments chemical reagents Safe Food Manufactory Safe Food Packaging
Contact: April Yu
Telephone: 86-21-62797338; Fax: 86-21-62797337
Email: chinapharm@mdc.com.cn
Website: http://www.chinapharmex.com/

7th November 2006 at the Online in Online, USA [1056]
Beyond 2006 - Software and Services Trends for eClinical Trials
This web seminar will serve as a prelude to DIA’s conference, The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World taking place on December 6-7, 2006 in Baltimore, MD.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12332/06251.pdf

8th November 2006 - 10th November 2006 at the EMEA in Canary Wharf, London, United Kingdom [856]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
The primary goals of this course are to allow participants to: •Acquire a robust base in the fundamentals of the electronic reporting of ICSRs •Familiarise themselves with the electronic transmission of ICSRs and the ICH M2 safety and acknowledgment message specifications •Understand and apply the ICH E2B(M) specifications on clinical safety data management in the frame of good pharmacovigilance practices •Get hands on experience with the EudraVigilance reporting capabilities and query functions •Understand the concepts of the EudraVigilance Medicinal Product Dictionary and get some practical experience in working with it.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9410/06523.pdf

8th November 2006 - 10th November 2006 at the Venue: The Rembrandt Hotel in London, UK [972]
US PATENT PRACTICE - What Every European Practitioner Should Know
US and European patent practice differs in many essentials. This seminar is divided into three elements, which can be attended singly or together. The programme, with practical examples, will cover: a) Patent claim drafting, sufficiency of disclosure and claim interpretation, b)Statutory patent law and patent prosecution and c) Patent litigation, appeals, interferences, re-examinations and reissues. The course will give delegates a clear explanation of the US Patent system, enabling them to work more effectively with their US counterparts.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=98

8th November 2006 at the Venue: The Rembrandt Hotel in London, UK [971]
THE PERFECT MEDICAL DEVICE CLINICAL INVESTIGATION PLAN - How to Develop and Write a Clinical Investigation Plan for a Medical Device Study
The Clinical Investigation Plan/Protocol is a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical study and is regarded as an essential document. This practical workshop will take you through the evolution of a protocol from a primitive state to the final comprehensive document. There will be ample time for case study exercises and group discussions. Through this combination of presentations and exercises, delegates will learn how to put a Protocol together, what the usual pitfalls are and how to overcome them.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=506

9th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [975]
THE MANAGEMENT OF COPD AND ASTHMA
This conference will explore further our current understanding of the management of COPD and ASTHMA. These respiratory diseases cause more deaths in the UK than any other disease area, which in turn cause heavy social and economic burdens. We are bringing together acknowledged experts from academic, regulatory authorities and the pharmaceutical industry to discuss some exciting new avenues for therapeutic research
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=547

9th November 2006 - 10th November 2006 at the Venue: The Rembrandt Hotel in London, UK [974]
LEADING SUCCESSFUL PHARMA TEAMS - Maximising your Team Leadership skills
This intensive course equips team leaders with the practical tools and techniques to develop high-performing teams which maximise performance and deliver results. Working in the Pharmaceutical and Device industries has become increasingly challenging and fast moving. Previously, excellence in technical areas would have guaranteed a successful career. In future, to develop and even sustain your career you almost certainly will need to gain and build your team leadership skills in order to perform in your existing role or to gain promotion. Technical skills alone are unlikely to do this. Have you or your manager identified this need for you - to be a stronger leader?
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=530

9th November 2006 at the Venue: Harrington Hall in London, UK [973]
EFFECTIVE RECALL MANAGEMENT - For Pharmaceutical, Biotechnology, Veterinary & Fine Chemicals Industries, London
A Recall from the marketplace of a successful pharmaceutical product can be a significant challenge to even the best of companies. Incorrectly managed, it can result in a loss of confidence by the purchasing pharmacist/hospital and more importantly the re-establishing of a dependent patient on another formulation while the recall is in effect. From an industry perspective, it is important to ensure that all aspects of the Recall Procedure (from initial risk assessment, event investigation, the Recall Strategy and subsequent corrective and preventative actions) work smoothly and effectively. This seminar will discuss and address the various elements involved with Recall, how they can be managed effectively and what is required to enable a systematic approach to ensuring that the re-occurence of the event is minimised and/or eliminated.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=411

9th November 2006 - 10th November 2006 at the Venue: Hotel Ambassador in Barcelona, Spain [977]
BRAILLE REQUIREMENT FOR MEDICINAL PRODUCTS
12 months after the implementation of the EU requirements for Braille to be on the labelling of medicinal products and for patient information to be available in formats to suit the blind and partially sighted, it is time to review what has happened, understand some of the difficulties and learn by sharing experiences. Problems have arisen in understanding some of the requirements and how they can be put into practice. In addition to traditional technology, new technology is being introduced and there have been potential GMP issues. Braille on some packaging (pharmaceutical and non-pharmaceutical alike) is not readable because the impression is inadequate. This is a potential risk for patients and could result in Regulatory action. Associations working for the blind are seeking a high level of Braille readability.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=412

9th November 2006 - 10th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [1028]
CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ASTHMA
Respiratory disease causes more deaths in the UK than any other disease area. Chronic Obstructive Pulmonary Disease (COPD) and ASTHMA are common disorders which cause heavy social and economic burdens. This annual conference will explore further current understanding of the management of COPD and ASTHMA, and will bring together acknowledged experts from academic, regulatory authorities and the pharmaceutical industry to discuss some exciting new avenues for therapeutic research.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=550

13th November 2006 at the Venue: Harrington Hall Hotel in London, UK [978]
GENERIC MEDICINES in EUROPE: LAW, REGULATION & MARKETPLACE
The impact of generic medicines on the pharmaceutical industry as a whole would be hard to overstate. It is the inevitable launch of generic medicines that limits the profitable life of Big Pharma's blockbusters - indeed, having a spate of products becoming open to generic competition simultaneously can bring even the most solid blue-chip giant to its knees. And with ever-growing concerns about the spiralling costs of medicines, it seems that governments across the globe are increasingly seeing generic medicines as a cost-limiting solution, with active steps being taken in many countries to encourage their generics markets. Furthermore, if the problems holding back the entry of biogenerics into the picture can be overcome, the impact of generics will be felt in areas of the industry hitherto untouched. This meeting aims to explore some of the core aspects and key drivers in the generics industry. As well as an overview of the commercial realities of generics market, the all-important legal aspects that govern the market - and determine whether generic competition is possible or not - will be examined. There is also an examination of the interplay between the two and how the regulatory side does not exist in isolation from the commercial but has a direct impact on it. The particular features of the regulation of small-molecule generics will be discussed in detail, and finally the rapidly developing area of biogenerics will be explored. As is vital for any discussion of a fast-changing field such as this, all speakers will look to the future as well as to the present, to explore likely course of the ongoing evolution of the generics industry.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=311

13th November 2006 - 16th November 2006 at the Crowne Plaza Union Square in San Francisco, CA, USA [857]
The Leadership Experience
The Leadership Experience is a 3 1/2-day session in which participants, working in a group, assume senior management roles. They analyze information, make decisions, and deal with the consequences of their decisions. There is special emphasis on the skills required to establish cooperation, diagnose and correct dysfunctional groups, and combine the skills of multiple people to accomplish what cannot be done alone. This is a VERY intensive program designed for those who are serious about improving their leadership skills.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9279/06405.pdf

13th November 2006 - 14th November 2006 at the Hyatt Regency Washington on Capitol Hill in Washington, DC, USA [858]
European Regulatory Affairs
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection. Key Topics •Centralized, Mutual Recognition and National Registration Procedures in the EU. •Official regulatory policies and other issues pertinent to successful EU regulatory strategy. •EU regulatory strategy pertinent to commercial, business, and licensing arrangements. •Trademarks and patents. •Medical devices. •Clinical Trial Directive. •Legal status and switching.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9319/06411.pdf

13th November 2006 at the Hilton Inn at Penn in Philadelphia, PA, USA [859]
Overview of Drug Development
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA. The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines. Key Topics: •How the pharmaceutical industry identifies new products and brings them to market. •Contributions of key groups within the company and how they interact. •FDA and regulation of the industry.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9333/06423.pdf

13th November 2006 - 17th November 2006 at the Charleston Place in Charleston, SC, USA [863]
Investigational Supply Process Training Course
This course is designed to provide an understanding of the many details to consider in the design, preparation, and packaging of clinical trial materials within the regulatory framework of disciplined clinical studies. The course encourages interaction and participation through small group case studies and roundtable discussions that emphasize the key concepts underlying the planning, implementation, and logistics of clinical supply projects. Key Topics •Techniques That Streamline The Clinical Supply Process •Interrelationships of the clinical supply pharmacist, clinical research associate, medical monitor, regulatory professional, compliance officer, clinical pharmacist, and quality assurance auditor •Current Good Manufacturing Processes (cGMP) and Good Clinical Practices (GCP) concepts applicable to the investigational supply process •Sponsor obligations during the preparation, use, and return of investigational materials.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11169/06451ISP.pdf

13th November 2006 - 15th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [861]
Regulatory II: The CTD/NDA Phase
The course will focus on drug and well-characterized biological products, and not the regulatory process for devices or generic products, or the abbreviated NDA. This course describes the regulatory background of the NDA and provides an overview of preparing an NDA in CTD format for submission to the FDA. Key Topics •Overview of FDA. •Roles and responsibilities of FDA. •Regulatory requirements for drug approval. •Pertinent regulatory processes and forms. •Overview of the CTD format. •Post-approval and marketing regulatory requirements and processes.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9398/06433%20November%20update.pdf

13th November 2006 - 14th November 2006 at the Hilton Philadelphia City Avenue hotel in Phyladelphia, USA [919]
e-Communication and Online Marketing Conference
Whether your company has recently started its web activities or is improving its advanced online features, the e-Communication and Online Marketing Conference will help you discover how and why the new communication paradigms and techniques will increase your products awareness, improve your interaction with customers and build and foster a sense of community among your clients and partners. The e-Communication and Online Marketing Conference (13 th -14 th of November, Philadelphia) has the ambitious aim of constituting a unique platform for discussing, understanding and evaluating what New Technologies can do for the Pharma sector and how Information and Communication Technologies can make a difference for your company's growth.
Contact: Alice Pilia Conference Director
Telephone: Toll Free USA: 1 800 814 3459 x 292; Fax:
Email: apilia@eyeforpharma.com
Website: http://www.eyeforpharma.com/edetailusa/index.shtml

14th November 2006 - 17th November 2006 at the 30 Pavillion road in London, United Kingdom [798]
the 4-day Pharma MBA
A 4-day practical and interactive programme developing the high performance manager in the pharmaceutical industry.
Contact: Sonia Tavanai Tamanai
Telephone: +44 (0)207 749 4747; Fax: +44 (0)207 7296110
Email: sonia.tavanai@falconbury.co.uk
Website: http://www.falconbury.co.uk/event

14th November 2006 at the Venue: Harrington Hall Hotel in London, UK [980]
POST CONFERENCE WORKSHOP: ACCELERATING THE REGISTRATION PROCESS - A workshop discussing the Importance of Regulatory Processes to Commercial Success
The impact of generic medicines on the pharmaceutical industry as a whole would be hard to overstate. It is the inevitable launch of generic medicines that limits the profitable life of Big Pharma's blockbusters - indeed, having a spate of products becoming open to generic competition simultaneously can bring even the most solid blue-chip giant to its knees. And with ever-growing concerns about the spiralling costs of medicines, it seems that governments across the globe are increasingly seeing generic medicines as a cost-limiting solution, with active steps being taken in many countries to encourage their generics markets. Furthermore, if the problems holding back the entry of biogenerics into the picture can be overcome, the impact of generics will be felt in areas of the industry hitherto untouched. This meeting aims to explore some of the core aspects and key drivers in the generics industry. As well as an overview of the commercial realities of generics market, the all-important legal aspects that govern the market - and determine whether generic competition is possible or not - will be examined. There is also an examination of the interplay between the two and how the regulatory side does not exist in isolation from the commercial but has a direct impact on it. The particular features of the regulation of small-molecule generics will be discussed in detail, and finally the rapidly developing area of biogenerics will be explored. As is vital for any discussion of a fast-changing field such as this, all speakers will look to the future as well as to the present, to explore likely course of the ongoing evolution of the generics industry.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=548

14th November 2006 at the Venue: Harrington Hall Hotel in London, UK [981]
THE ROLE OF THE QUALIFIED PERSON IN PHARMACOVIGILANCE - Implications of Volume 9A
Each Marketing Authorisation Holder placing medicinal products on the European Union market should have in place a Qualified Person for Pharmacovigilance. Experience during recent regulatory inspections indicated that there is now greater emphasis being placed on the role of the Qualified Person for Pharmacovigilance within the EU, with significant penalties liable to be imposed for non-compliance with this requirement. This seminar will offer guidance from members of Industry and the Regulators as to the requirements, including proposed updates in Volume 9a of the Notice to Applicants, and examples given of role models used in different sized companies. Special problems will be discussed, with practical advice as to fulfilling the legal requirements
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=534

14th November 2006 - 16th November 2006 at the JW Marriott Hotel in Dubai, United Arab Emirates [864]
DIA 7th Middle East Regulatory Conference (MERC)
Since its inception nearly 10 years ago, the Middle East Regulatory Conference has grown to become an important forum for discussion of matters related to the provision of healthcare in the region, with a specific focus on issues around the evaluation and supervision of medicines for human use. The conference offers the opportunity for key stakeholders active in the region, including representatives from ministries of health, local and multinational pharmaceutical companies, to meet to exchange views, discuss topics of interest and identify actions to increase patient access to new and improved medicines and therapies. Key Issues •Updates on global regulatory developments. •EU New Medicines Legislation and how it will impact regulatory requirements. •Clinical trial data availability Middle East Regional Regulatory Developments (including GCC-DR update). •Importance of product lifecycle management. •Procedural aspects of variations systems. •Procedural aspects of urgent/non-urgent labelling changes. •Pharmacovigilance - mechanisms for gathering and disseminating data. •Elements of quality review in the Middle East.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6100
Email: dia@diahome.org
Website: http://www.diahome.org/product/9267/06104.pdf

15th November 2006 - 15th December 2006 at the The Great Room, Grosvenor House Hotel in London, UK [875]
Scrip Awards 2006
The Scrip Awards recognise individuals and companies who have made an outstanding contribution to furthering the goals of their organisation and improving global health. Winning an award is the mark of global distinction and is the highest level of professional acknowledgment within the pharmaceutical and biotechnology industries today. To sponsor an award, enter or reserve your seat please contact Charlotte Garratt mailto:charlotte.garratt@informa.com
Contact: Charlotte Garratt
Telephone: +44 (0)20 7017 5173; Fax: +44 (0)20 7017 6787
Email: charlotte.garratt@informa.com
Website: http://www.scripawards.com/

16th November 2006 - 17th November 2006 at the Venue: The Rembrandt Hotel in London, UK [983]
PATENT SYSTEMS IN EUROPE - A Schematic Overview
This valuable two-day course aims to provide a unique schematic overview of the multinational aspects of the Patent System in Europe, with selected topics being discussed in depth A brief outline of the various patent-related international treaties in force will be followed by a more detailed examination of both the European Patent Convention (EPC) and the Patent Cooperation Treaty (PCT). The interface between the two systems will be explained. The forthcoming changes to the EPC and the PCT Rules will also be outlined.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=514

21st November 2006 at the Venue: The Rembrandt Hotel in London, UK [985]
DRAFTING INTELLECTUAL PROPERTY AGREEMENTS IN THE BIOTECH AND PHARMACEUTICAL INDUSTRIES - Drafting skills and legal and commercial issues
The course will focus on drafting skills and legal and commercial issues affecting a range of agreements that concern intellectual property within the pharma/biotech industries, including confidentiality agreements, material transfer agreements, term sheets, IP licences and assignments and IP terms in R&D contracts. Practical exercises and discussion
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=489

21st November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [984]
REGULATORY UPDATE ON ANIMAL FEED ADDITIVES
As a result of the EU White Paper on Food Safety published in 2000, there have been sweeping changes to legislation concerning the food chain, especially feed and feed additives. The EU feed additive regulation (EC No. 1831/2003) replaced the existing feed additive Directive 70/524/EEC and introduced a new system for assessing feed additive dossiers. The new evaluation procedure involves the EU Commission, EFSA (European Food Safety Authority) and the Standing Committee on the Food Chain and Animal Health, which includes delegations from 25 EU Member States. The EU plans to review all currently authorised feed additives within the next decade, most likely starting with groups of additives that are considered to represent a potential safety hazard to animals, workers, consumers or the environment. Many existing feed additives have never before been subjected to an EU assessment according to current standards of safety, quality and efficacy.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=504

22nd November 2006 at the Venue: The Rembrandt Hotel in London, UK [986]
MANAGING SUCCESSFUL EU FEED ADDITIVE EFFICACY TRIALS
The new feed additive Regulation (EC) 1831/2003 lays down the procedure for approval of feed additives intended for placing on the EU market.The approval process requires demonstration of the efficacy of the additive in relation to feed characteristics, animal nutrition, produce or performance, or the environment. Hisotomonstats and coccidiostat feed additives must also demonstrate efficacy under defined conditions. Silage agents, amino acids and urea are considered as feed additives for the first time.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=505

23rd November 2006 - 24th November 2006 at the Venue: The Rembrandt Hotel in London, UK [987]
RISK MANAGEMENT OF MEDICAL DEVICES AND EU VIGILANCE
The safety and risk management of medical devices are becoming ever more important issues to be addressed by manufacturers. In addition Post Market Surveillance (PMS) and Vigilance are very significant elements of risk management. What effect will the current review of the Medical Device Directives have on risk management and analysis? Standards change, expectations increase and information is now more available and transparent. The recent increase in FDA product recalls highlights the necessity to have an established risk management system in place. This interactive seminar will look at the risk management standard, product liability, biological safety, PMS and will also provide a detailed practical opportunity to learn the various ways in which a risk analysis may be performed. Understanding how to manage risk is paramount to the success of a medical device company.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=507

24th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [988]
ADVANCED FORMAL REQUIREMENTS OF EPO for administrative staff and paralegals
This course has been designed to give a practical, in-depth understanding of the inner workings and finer details of the formal requirements of proceedings before the European Patent Office. Apart from addressing very specific items of procedure, participants will be given the opporunity to raise specific problems, and practical solutions will be put forward and discussed. It is for those who have extensive experience of filing before the EPO or who have attended the Management Forum course Guide to the Formal Requirements of the European Patent System.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=110

27th November 2006 - 29th November 2006 at the The Moller Centre in Cambridge, UK [925]
Tabletting Technology for the Pharmaceutical Industry
This well-established course provides an intensive course of study on the formulation, production and drug-release characteristics of pharmaceutical tablets. The course will cover the basic concepts of equipment selection, granulation and end-point determination, formulation optimisation and prediction, in-process monitoring (PAT), official and non-official dissolution tests, and film coating. It deals with development pharmaceutics for registration. The lectures will describe the current state of knowledge of the subject, both in terms of theoretical basis and practical experience. The workshops provide opportunities for discussion in small groups of real-life problems encountered in tabletting and will draw on a sound theoretical knowledge of the principles involved in the processes.
Contact: Lisa Gilbert
Telephone: 020 7572 2261; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org.uk/pdfs/scires0611.pdf

27th November 2006 at the Venue: The Rembrandt Hotel in London, UK [989]
DATA PROTECTION ISSUES IN THE PHARMACEUTICAL INDUSTRY
Legislation on data protection is having a significant impact on the work of the pharmaceutical, industry. The seminar will examine the effects European and UK Laws will have on clinical development , market support of new medicines and pharmacovigilance. Topics will include the philosophy and objectives of the European Data Protection Directive, the UK Data Protection Acts, the concepts of the consent, processing, sensitive data, safe havens, the types of research affected by data protection as well as strategies for the future. The relationship between data protection and intellectual property will also be covered
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=531

27th November 2006 - 28th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [967]
Best Practices and Development of Standards for the Submission of Genomic Data to the FDA
This two-day workshop includes a series of presentations pertaining to the present state of the Best Practices Document, as well as what can be expected once the document becomes final later this year. Topics will include: • Scientific accomplishments showcased in Voluntary Genomic Data Submissions (VGDS) over the past two years. • Consensus from Q&A sessions about the added value of genomic data in regulatory review. • New applications associated with VGDS, including other omic platforms and estimates for the impact of pharmacogenomic information in clinical trials. • Role of VGDS in the Biomarker Qualification Pilot Process. • Best Practices and Development of Standards in the Submission of Genomic Data to the FDA. SPECIAL FEATURES Spirited discussion of the VGDS experience Breakout sessions to discuss best practices and standards in the submission of genomic data.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12225/06036.pdf

27th November 2006 - 28th November 2006 at the Renaissance Paris Hotel La Defense in Paris, France [865]
European Regulatory Affairs
The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development. Key Topics •European Union. •Centralized Procedures. •DeCentralised Procedure. •Mutual Recognition Procedure. •National Procedure. •Key Issues to Consider for Business Opportunities. •Regulatory Strategy. •Legal Status of Products and Switching from Rx to OTC. •Medical Devices Legislation. •Clinical Trial Directive.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9224/06505.pdf

27th November 2006 - 1st December 2006 at the Renaissance Paris Hotel La Defense in Paris, France [841]
Pharmacovigilance Training: Clinical Trials and Marketed Products
This course is designed to provide a firm grounding in key aspects of Global Clinical and Post Marketing Safety. This five-day training course, presented by EMEA, is the only one of its kind. Key Topics: Definitions and Methods in Pharmacovigilance. Regulatory Aspects in Pharmacovigilance and Practical Examples. Diagnosis and Management of Adverse Drug Reactions. Risk Management.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11005/06537.pdf

28th November 2006 at the Venue: Harrington Hall Hotel in London, UK [990]
PHARMACOVIGILANCE ASPECTS OF LICENSING AGREEMENTS - Essential for those involved in Drug Safety & Licensing Agreements
Whilst licensing agreements involving pharmaceuticals are primarily driven by commercial considerations, the successful handling of the pharmacovigilance and safety data exchange sections of the contract is a critical, but frequently overlooked, consideration. Negotiating the safety arrangements of the agreement to ensure compliance by both partners can be a complex process. This is further compounded by lack of harmonisation and clarity of the regulations around the world. This seminar will review the existing global requirements relating to pharmacovigilance in contractual agreements and will offer guidance from members of industry and the regulators, with examples of different role models used by companies from the three ICH regions. The emphasis will be on practical advice as to how to remain compliant with the legal requirements as well as how to promote harmonious business partnerships
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=535

28th November 2006 at the Venue: Harrington Hall Hotel in London, UK [991]
THE NEW ROUTES TO REGULATORY APPROVAL IN EUROPE ~ ONE YEAR ON - What are the Key Strategic and Practical Issues
The implementation of the new European Pharmaceutical Legislation in October 2005, introduced significant changes to the regulatory routes to approval of medicinal products in the European Union. The new Decentralised Procedure was established and significant changes have been made in the operation of the Mutual Recognition Procedure. Within the scope of the New Pharmaceutical Legislation an ever increased focus has been placed on the Centralised procedure with a number of changes being implemented to facilitate faster access to new innovative medicines. To be successful in this new Regulatory environment it is important for the pharmaceutical industry to understand the strategic and practical issues that have arisen from the implementation of the new legislation. One year on the purpose of this meeting is to reflect on the experience gained to date. In so doing, the meeting will examine the key legislative changes in the routes to regulatory approval in the EU and will provide an understanding of the strategic and practical issues and opportunities that result. Perspectives from the Regulators and Industry will consider practical advice on how to run a successful Decentralised Procedure, changes to the Mutual Recognition Procedure, impact for generic products and the new opportunities provided within the Centralised procedure.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=532

28th November 2006 - 29th November 2006 at the Venue: Harrington Hall Hotel in London, UK [993]
CALIBRATION MANAGEMENT
This seminar will discuss the contents of the 'Good Practice Guide - Calibration Management'.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=447

29th November 2006 - 30th November 2006 at the Doubletree Hotel Philadelphia Philadelphia, PA in Philadelphia, PA, USA [964]
5th Annual Contract Manufacturing for Pharmaceuticals: Optimizing Outsourcing Relationships to Ensure Quality and Profitability
Contract Manufacturing for Pharmaceuticals will teach you proven strategies for outsourcing your manufacturing functions. Attend this conference to learn from industry leaders about: · Selecting the right contract manufacturing organization (CMOs) ·Developing quality agreements ·Managing and tracking performance ·Building relationships with CMOs ·Assuring quality of product This conference was developed with your specific challenges in mind. A unique panel discussion has been created based on your feedback. Attend this conference and hear from WATSON PHARMACEUTICALS, ABBOTT LABORATORIES, and MERCK & CO, INC. about their experiences in working with CMOs.
Contact: Erica
Telephone: ; Fax:
Email: ecrowder@iqpc.com
Website: http://www.iqpc.com/na-10854-001/ediary

29th November 2006 at the Online in PA, USA [1088]
FDA Withdraw of Three Guidances for eSubmissions
Learn Why the FDA Withdrew Three Guidances for eSubmissions On September 29, 2006, the FDA’s Center for Drug Evaluation and Research announced the withdrawal of three guidances for eSubmissions. These Guidances covered: •New Drug Applications (NDAs) •Abbreviated New Drug Applications (ANDAs) •Annual Reports for NDAs and ANDAs WEBINAR HIGHLIGHTS •Why previous guidances are no longer consistent with more recent guidances •Why they no longer reflect the Center’s preferred format for receiving electronic submissions •Why the eCTD format is now preferred by the FDA.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12421/06252.pdf

29th November 2006 at the Venue: Harrington Hall in London, UK [994]
HVAC FOR PHARMACEUTICAL MANUFACTURING
The manufacture of pharmaceutical products requires specialised and controlled environments and the HVAC System is the control of these environments. This seminar will review the types of systems and the nature of the HVAC Systems for a wide range of dosage forms.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=414

29th November 2006 at the Venue: To be announced in London, UK [995]
INJECTABLE AESTHETICS - Skin Rejunvenation
In this workshop you will learn the advanced techniques in total lip contouring, facial contouring, asymmetric balancing, non surgical brow lift, filler techniques to give a youthful face and more. This will include a special segment on skin-rejuvenation with the latest intradermal techniques with Hyaluronic Acid
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=544

30th November 2006 - 1st December 2006 at the Venue: Harrington Hall Hotel in London, UK [996]
MEDICAL DEVICE REGULATION IN JAPAN, GREATER CHINA (PRC), HONG KONG
Now that the Europoean Medical Device market is well established, the new growth area is Japan. Japan, China, Taiwan, Hong Kong and other countries have all implemented , or are in the process of implementing, their own medical device regulations and developments in these countries and give practical guidance on how to comply with the requirements and gain access to these growth markets.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=524

December 2006

1st December 2006 at the Venue: The Rembrandt Hotel in London, UK [997]
HIGH PERFORMANCE BUSINESS SKILLS FOR PHARMA SUPPORT STAFF
This enjoyable one day course will help you work more efficiently and gain greater credibility in todays pharmaceutical industry. You wil have a greater understanding of the business jargon and how to achieve your potential whilst adding value to your organisation. You will also learn to organise your thinking more effectively, present your ideas and communicate more effectively. You will be able to show greater iniative and come across with more professionalism so as to be able to take a great responsibility in your organisation.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=539

3rd December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [932]
Are Your Intellectual Assets at Risk? Leveraging knowledge management and legal strategies to address the tension between the dissemination and protection of scientific information
Knowledge Management (KM) is an integrated approach to identifying, managing, and sharing a company’s knowledge-based intellectual assets. As an industry sector dependent on innovation, embedding best practice in KM is key to ensuring continued success. While technology is an important enabler, addressing a knowledge culture and process is currently the greatest challenge. How far should we go? Should we seek to control and direct what people have come to know, what they have delivered as output and then enable it to be securely distributed? KM enables more efficient and effective team-based communication, cooperation and collaboration. The value of intellectual assets is a function of their ability to be shared – but to the right people at the right time; managing their security while providing appropriate distribution is a major challenge and needs clear management structures to ensure that there is responsibility for managing these assets. As companies increasingly seek to globalize their business models, the challenges we face are multiplied; language, time zone, and cultural differences are just some examples. Current and emerging knowledge management systems coupled with a clear legal strategy, business process model and management focus can substantially minimize these challenges.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11204/06031.pdf

3rd December 2006 - 5th December 2006 at the Shores Resort & Spa in Daytona, Florida [931]
FUTURE PHARMA CONGRESS
Who should attend? C-Level Executives representing the Pharmaceutical Manufacturing Industry and related areas. Details: On December 3rd 4th and 5th in Daytona, Florida, some of the world’s top executives in the pharmaceutical industry are coming together. For 3 days of Keynote presentations, workshops and panel discussions, designed to help facilitate the advances that need to be made in order for these organizations to remain innovative and at the forefront, within their markets. Pharmaceutical Congress Quick Facts: •Title: The Future Pharmaceutical Congress •Private | Invitation Only Corporate Event •Link attending speakers thus far: http://virtusinternational.com/pharma/speakers.html •Date: December 3-4-5, Daytona, Florida Delegation includes 150 VP and C-Level Executives representing the Pharmaceutical Manufacturing Industry. Also included a link to our past speakers for Medial Device and R&D forum we produced this past March: http://virtusinternational.com/medical/speakers.html
Contact: Director of National Accounts, Pierre Juillet
Telephone: 514.989.9111 X:211; Fax: 514-989-8773
Email: jessicaa@virtusinternational.com
Website: http://virtusinternational.com/pharma/speakers.html

3rd December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [1082]
7th European Electronic Document Management Conference
The need and opportunity for managing records and regulatory submissions electronically, has never been so great in the pharmaceutical industry. This poses great challenges for business process, for industry standards and for related technologies so as to ensure quality and compliance over the full lifecycle of information management. Whether your organisation is entering electronic information management for the first time, optimising established processes and systems or pushing the boundaries of document and content management, it is vital for decision making within business to be based on up-to-date information concerning industry and technological standards, and on current Regulatory Agency expectations and the industry's response.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11153/Final_06114_25oct.pdf

4th December 2006 - 6th December 2006 at the Renaissance Scottsdale in Scottsdale, AZ, USA [866]
Advanced Topics in Clinical Research/Drug Development
This course reviews the identification and development of new therapeutic agents and the management of clinical development programs through interactive lecture and hands-on workshop training methods. Topics addressed include industry challenges, clinical operations, key documents, and quality concepts. The content for this course focuses on drugs and biologics development. Key Topics •Industry challenges: product identification and development, multinational studies. •Clinical operations: clinical process overview, project and resource management, ethics/hipaa. •Key documents: protocol development, crfs/data collection devices, study reports, nda/ctd preparation. •Quality concepts: study management and auditing.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9332/06422.pdf

4th December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [869]
7th European Electronic Document Management Conference
The need and opportunity for managing records and regulatory submissions electronically, has never been so great in the pharmaceutical industry. This poses great challenges for business process, for industry standards and for related technologies so as to ensure quality and compliance over the full lifecycle of information management. Whether your organisation is entering electronic information management for the first time, optimising established processes and systems or pushing the boundaries of document and content management, it is vital for decision making within business to be based on up-to-date information concerning industry and technological standards, and on current Regulatory Agency expectations and the industry's response.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11153/06114.pdf

4th December 2006 - 5th December 2006 at the University of California Washington Center 1608 Rhode Island Ave. NW in Washington, DC, US [1058]
The Lewis B. Sheiner Memorial Symposium
The University of California, School of Pharmacy, Department of Biopharmaceutical Sciences, and the Center for Drug Development Science are pleased to announce the Lewis B. Sheiner Memorial Symposium, celebrating the seminal contributions in pharmacometrics innovated by the late Professor Sheiner. Former fellows, colleagues and friends of Lewis will gather to present latest developments that reflect his key scientific contributions, including therapeutic optimization and PK prediction in individual patients, individual and population PK/PD modeling and estimation, quantitative drug development science (modeling & simulation), and epistemology in drug development and drug regulation (causal evidence of effectiveness). A theme for discussion and debate throughout the conference will culminate in recommendations for a Model Curriculum in Pharmacometrics. A special session will be held on Sunday, December 3 for former Sheiner research fellows, students and visiting scientists featuring presentations and remembrances by these former members of Dr. Sheiner’s research team. The Memorial Symposium will be the forerunner of the Lewis B. Sheiner Lectureship in Pharmacometrics.
Contact: Bill Karpowicz
Telephone: ; Fax:
Email: info@sheinersymposium.org
Website: http://www.sheinersymposium.org/

4th December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [870]
1st Annual Cardiac Safety Conference
Recent developments in the regulatory approach to drug safety in clinical drug development have triggered significant changes in the requirements for new drug applications and criteria for marketing approval. The new requirements, have now been adopted by the ICH organisation (topic E14) for global implementation and are mainly concerned with repolarisation-based (QT prolongation) Cardiac Risk Assessment (CRA). At the centre of these recent initiatives is the need for a well designed, well executed Through QT (TQT) Study with relevant statistical interpretation to ensure the cardiovascular safety of drugs in development. In addition, recent concerns involving certain COX-2 specific NSAID have highlighted the need for broader cardiac safety surveillance and Cardiac Risk Management (CRM) programmes, extending well beyond regulatory approval into the marketing stage. These concerns have now triggered further regulatory reviews of the drug development process and are expected to introduce further changes to the drug approval process and the post marketing commitments of drug manufacturers. This programme will review and address the above cardiac safety topics and will bring industry, academic and regulatory experts and representatives together with the aim of exchange of ideas and sharing information with the audience.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11247/06116.pdf

4th December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [867]
Leveraging Knowledge Management Processes and Available Legal Protections for Secure Capture, Storage and Distribution
Knowledge Management (KM) is an integrated approach to identifying, managing, and sharing a company’s knowledge-based intellectual assets. As an industry sector dependent on innovation, embedding best practice in KM is key to ensuring continued success. While technology is an important enabler, addressing a knowledge culture and process is currently the greatest challenge. How far should we go? Should we seek to control and direct what people have come to know, what they have delivered as output and then enable it to be securely distributed? KM enables more efficient and effective team-based communication, cooperation and collaboration. The value of intellectual assets is a function of their ability to be shared – but to the right people at the right time; managing their security while providing appropriate distribution is a major challenge and needs clear management structures to ensure that there is responsibility for managing these assets. As companies increasingly seek to globalize their business models, the challenges we face are multiplied; language, time zone, and cultural differences are just some examples. Current and emerging knowledge management systems coupled with a clear legal strategy, business process model and management focus can substantially minimize these challenges.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11204/06031.pdf

4th December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [915]
Electronic Patient Reported Outcomes (ePRO) Update: The Quest to Move from Paper to Plastic
Patient reported outcomes continue to be of increasing importance in assessing efficacy of new pharmaceutical products. Translating these measurements to the electronic world has brought evolving challenges. This unique conference will address an update to key elements in the adoption of electronic patient reported outcomes (ePRO) for use in the pharmaceutical industry. KEY TOPICS •Technology Aspects of the FDA PRO Guidance •From Paper to Electronic Diaries •Best Practices for Investigative Sites and Site SOPs •Selecting an Appropriate ePRO Technology.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11404/06025.pdf

4th December 2006 - 5th December 2006 at the Venue: The Rembrandt Hotel in London, UK [998]
THE CLINICAL TRIAL & GCP DIRECTIVES - An Interactive Workshop
The Clinical Trial Directive and the New GMP Directive are having major implications on how clinical trials are being managed in the EU. There are also several additional CT/GCP Directive guidelines which are due to be released to complete the Directives' requirements. EU countries have now transposed the main requirements of the CT Directive into national legislation, but in many countries Further Degrees, guidelines and other documents are being issued to complete the implementation. This transition period (until all the national requirements are fully implemented) has proven a challenge for many organisations seeking to carry out clinical trials in the EU. The Timing of the workshop is ideal ~ in that it provides an excellent opportunity to share experiences and discuss the current issues.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=533

5th December 2006 - 7th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [871]
The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World
The clinical development life cycle has become increasingly complex and challenging scientifically while remaining inefficient and costly. The financial commitment needed to bring drug products to market continues to soar. It is crucial to develop technology solutions that work together and increase the speed and quality of the clinical trial process so that better answers about the safety and efficacy of investigational and marketed products are available to sponsors, agencies, investigators and the public more rapidly. With electronic healthcare just around the corner, industry faces increasing pressure to adopt enabling technology to optimize and accelerate drug development. But which technology, which tools, what initiatives are the most important ones to keep on your radar screen? If you are struggling with these questions, this conference is for you! •What technology and standards development initiatives are most critical to the biopharmaceutical industry and why? •How can you leverage some of the work underway in government agencies and standards-setting organizations and when? Which will have the most impact on our industry? •What information do you need to set priorities now, plan for future developments, and ensure quality and compliance? The information presented at this conference will help your organization compete….
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11116/06029.pdf

5th December 2006 - 6th December 2006 at the Venue: De Vere Cavendish in London, UK [999]
LABORATORY EQUIPMENT QUALIFICATION & COMPUTERISED ANALYTICAL SYSTEMS VALIDATION - Risk Based Approach "
The demonstrable validity of analytical methods and systems used to generate data either in support of Marketing Authorisations or for release of product onto the market, is seen by Regulatory Authorities as a key area for compliance. Proper procedures and practices for installation, qualification and calibration of analytical instrumentation is vital for the establishment of an operational baseline to support on-going performance monitoring to ensure demonstrable compliance. In addition, the software components associated with the instrument and system must be shown to be fit for their intended purpose. The objective of this seminar is to provide delegates with an appreciation of the regulatory requirements for qualification of analytical equipment and computerised analytical systems. Practical advice on risk assessment strategies and approaches to calibration, validation and routine monitoring of instrumentation and systems will be given. Both prospective and retrospective requirements will be covered and the interactive workshops will allow key areas of delegate interest to be addressed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=415

6th December 2006 - 7th December 2006 at the Rosen Shingle Creek Report in Orlando, Florida, [968]
Biopharmaceutical Manufacturing & Development Summit
The Forum to Address the Industry’s Fastest Changing and Most Critical Topics by Bringing Together Expert Faculty and Interdisciplinary Teams Choose from 3 cutting-edge tracks IBC’s 3rd Disposables for Biopharmaceutical Production A Case Study Forum on the Validation, Design, Planning, and Implementation of Disposable Bioprocess Systems • Customer and supplier responsibilities for extractables and leachables • Implementation of single-use technologies from clinical to commercial scale manufacturing • Process models to minimize upfront investment of disposable technologies IBC’s Inaugural Challenges in Raw Materials Sourcing and Safety Speeding Process Development and Increasing Manufacturing Efficiency • Benchmark your risk assessment and management • Control change and ensure consistency • Learn supplier audit techniques IBC’s International Flexible Operations and Capacity Planning Maximizing Throughput and Efficiency in Multi-Product and Existing Biopharmaceutical Production Facilities • Wyeth’s 5000-fold increase in protein per batch • Genentech’s doubling of purification capacity in transferable process • Assess the buy, build or retrofit decision • Amgen’s yield improvements through PAT
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/BMD

6th December 2006 - 7th December 2006 at the Ritz-Carlton in Berlin, Germany [1059]
Pharma Packaging & Labelling 2006
Conference designed to assess the various technological and regulatory issues around the pharmeceutical packaging industry. Topics include: - Complying with recent braille directives - Current anti-countfeiting strategies and technologies - Efficiently coordinating international labelling requirements - Finding out latest innovative technologies - Developing pharmeceutical packaging to enhance patient complience
Contact: Chris Howard Marketing Executive SPG Media
Telephone: ; Fax:
Email: chrishoward@spgmedia.com
Website: http://www.pharmapackaging-events.com/

6th December 2006 - 7th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [1083]
The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World
The clinical development life cycle has become increasingly complex and challenging scientifically while remaining inefficient and costly. The financial commitment needed to bring drug products to market continues to soar. It is crucial to develop technology solutions that work together and increase the speed and quality of the clinical trial process so that better answers about the safety and efficacy of investigational and marketed products are available to sponsors, agencies, investigators and the public more rapidly. With electronic healthcare just around the corner, industry faces increasing pressure to adopt enabling technology to optimize and accelerate drug development. But which technology, which tools, what initiatives are the most important ones to keep on your radar screen? If you are struggling with these questions, this conference is for you!
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11116/06029.pdf

6th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1000]
BASIC INTRODUCTION TO INTELLECTUAL PROPERTY - For Administrators, Secretarial and Support Staff
This course has been designed for administrators, secretaries and other support staff who are employed to maintain the work of an in-house Intellectual Property department or private practice firm. The comprehensive programme will provide an invaluable overview of the key aspects of intellectual property including the basics of what can be protected, what procedures are involved to achieve protection, what constitutes infringement of a patent and how patents may be enforced.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=188

6th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1001]
DRUG DEVELOPMENT - For Pharmaceutical Administrators & Support Staff
The course will provide a step by step description of the main areas of drug development and will discuss the roles and responsibilities of key staff involved as well as explaining the terminology. It will enable the participants to understand their contribution to the team and help them become more effective, professional and motivated in their daily work.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=117

6th December 2006 at the Hotel to be Announced in London, UK [1002]
INJECTABLE AESTHETICS - Skin Rejuvenation
In this workshop you will learn the advanced techniques in total lip contouring, facial contouring, asymmetric balancing, non surgical brow lift, filler techniques to give a youthful face and more. This will include a special segment on skin-rejuvenation with the latest intradermal techniques with Hyaluronic Acid THIS COURSE IS ALSO BEING HELD ON 29th NOVEMBER.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=528

7th December 2006 - 11th December 2006 at the Crowne Plaza, Hotel Park View Wuzhou, NO. 8 North Si Huan Zhong Road, Beijing, 100101 CHINA in Beijing, China [810]
1st International China Biopharmaceutical Symposium (ICBPS)
The Chinese Pharmaceutical Association (CPA), the China Biochemical Pharmaceutical Industry Association (CBPIA) and Battelle Memorial Institute invite the international community to participate in their first joint symposium in China in the very exciting area of biopharmaceuticals and the market. With the increasing concern in emerging infectious diseases, bioterrorism events and natural disasters, is there enough access to needed active pharmaceutical ingredients (APIs)? What can China do to sell its products in all markets and what can other countries do to sell their products in China?  How do Western drug and biotech firms get reliable APIs from China and protect their patents and intellectual property (IP)?  How do Western drug and biotech firms work with Chinese firms to introduce and market their products in China?
Contact: Richard M. Price
Telephone: 410 638-9480; Fax: 410 638-9481
Email: info@icbps.org
Website: http://www.icbps.org/

7th December 2006 at the Hesperia Hotel in London, UK [1113]
Material functionality and fitness for purpose in sold dosage forms
In the drive to make more reliable and efficient processes and effective products, industry is increasingly realising the importance that controlling the properties of the input materials, including both API and excipients, has in achieving these objectives. This meeting explores some of these important properties and the philosophy of the controls required.
Contact: Susan Hughes
Telephone: 020 7572 2640; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/worldofpharmacy/events/

7th December 2006 - 8th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1003]
ADVANCED PCT FORMALITIES COURSE
The seminar will give a practical, in-depth understanding of the inner workings and finer details of the PCT mechanism. There will be room for detailed discussion of very specific items of the PCT procedure, both international phase and entry into the national/regional phase. Participants wil be given the opportunity to raise specific problems, and practical solutions will be put forward and discussed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=320

7th December 2006 - 8th December 2006 at the Venue: The Harrington Hall Hotel in London, UK [1004]
THE PRACTICE OF ORAL PROCEEDINGS AT THE EPO - A practical, interactive and intensive course
Oral proceedings can occur during any stage of a European application. Each year, oral proceedings are appointed in about half of all opposition cases as well as over two-thirds of the appeal cases.This is in addition to several hundred in examination proceedings.Therefore at some point a European patent attorney will almost certainly have to appear at oral proceedings, either to defend a client's valuable invention or patent, or in an attempt to have patents held by the client's competitors revoked or limited in scope. A Patent Attorney's first experience of oral proceedings at the European Patent Office can be an intimidating experience, and it cannot be assumed that knowledge of their own national system will enable them to represent their clients to optimal effect. In order to defend a client's interests competently, it is vital to be properly prepared, and to know what to expect at this European level. This workshop will give participants an opportunity to increase their knowledge of current practice in the EPO and to develop confidence and skill in preparing for and appearing at oral proceedings at all levels.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=55

7th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1005]
US FDA QUALITY SYSTEMS REQUIREMENTS FOR MEDICAL DEVICES - FDA Inspections – Are You Prepared?
This one day seminar will address the US FDA Quality System regulation with emphasis on FDA's current focus. The US FDA requirements will be presented to compare and contrast with ISO13485 and ISO14971 Risk Management. Actual FDA Warning Letter examples will be used to illustrate key points. In addition, the FDA inspection process will be explained with advice on how to prepare your company to respond to 483s and Warning Letters.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=508

8th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1006]
US FDA CORRECTIVE AND PREVENTATIVE ACTION (CAPA) FOR MEDICAL DEVICES
More than 50% of FDA's 483 Observations and Warning Letters are Corrective and Preventative Action (CAPA) related. This one day seminar will address the requirements and expectations of CAPA to meet the US FDA medical device requirements.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=509

11th December 2006 at the Online in Online, USA [1130]
Bio-Pharma Meets Healthcare Information Technology @ HIMSS 2007
CDISC and IHE have organized the first concrete demonstration of interoperability between bio-pharma information systems and healthcare information technology. Building on an IHE integration profile known as Retrieve Form for Data-Capture (RFD), bio-pharmaceutical companies and electronic health record (EHR) vendors will demonstrate their work at the HIMSS 2007 Interoperability Showcase. This webinar foreshadows the Showcase, and explains the scenarios, the goals, and the current state of the development.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12590/06256.pdf

11th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1007]
VETERINARY GENERICS IN THE EU
Introduction 2004/28 came into force in October 2005, amending Directive 2001/82, and brought with it significant changes to the regulation of generic veterinary medicines in the European Union. This applies also to so-called 'branded generics' that are usually authorised by way of Article 13.1(a)ii (bibliographic dossiers) as well as to true generic products authorised according to Article 13. The changes have implications for both manufacturers of generic veterinary medicines and for research-based companies that seek to protect their products from competition. This seminar will examine the experience gained in implementing the new legislation to provide valuable advice to all in the animal health industry. The difficulties of authorisation of generic products in the Mutual Recognition and Decentralised Procedures will also be addressed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=499

11th December 2006 - 12th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1008]
THE EU PHARMACEUTICAL DOSSIER - CTD Modules 2.3 and 3
The conference will provide a wide-ranging, up-to-date coverage of the pharmaceutical issues that underpin a successful marketing authorisation application. In a carefully-structured programme, delegates will learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines, and will find out how to prepare the 'Quality' parts of the CTD (in Modules 1.3, 2.3 and 3). Information will also be given on common deficiencies in the pharmaceutical dossier. It is anticipated that the course will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas. All the speakers have had many years' experience working in or for the UK regulatory authorities and also for various other bodies with multi-national regulatory activities. There will be ample opportunity for question and answer sessions throughout the two days of the course, further to enhance the delegates' understanding of pharmaceutical issues of individual concern. PLEASE NOTE: THIS MEETING WILL BE HELD AGAIN IN JUNE 2007 IN NICE, FRANCE. THE DATES WILL BE CONFIRMED AT A LATER DATE.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=549

11th December 2006 - 12th December 2006 at the Venue: The Cafe Royal in London, UK [1009]
PORTABLE INHALERS: ANNUAL CONFERENCE
Delivery via the pulmonary route is in a significant growth period with some exciting therapies in clinical trials. Supporting this is the development of significant delivery technologies and understanding of the factors that improve patient use and compliance. This conference will consider the latest understanding of the Asthma disease state and how this is being used to develop new therapies. It will also discuss the benefits of inhaled insulin and the potential of this area. An overview of the inhaler market, growth areas and the generic company approach to this market are imperatives for senior managers and strategic business planners. This conference will also feature recent inhaler selection guidelines, patient inhaler selection studies and discuss the significance of patient inspiratory flow profiles, all fundamental in effective product design. This meeting is complimentary to the Dry Powder Inhaler Conference (June 2006) and will provide the latest advances associated with pressurised metered dose inhalers. These advances have overcome both delivery and patient use issues associated with the first generation pMDIs. Significant technology advances will be showcased, these advances offer real alternative product development strategies and need to be considered in any product development plan.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=286

11th December 2006 - 13th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1010]
THE PHARMA MINI-MBA - Cover the Core Curriculum of an MBA in just 3 days
This intensive three day course covers the core areas of an MBA and applies these skills to the pharmaceutical industry – using industry case studies and your own issues. This ‘Mini MBA’ is especially designed to build your management skills for the future and to enable you to more effective and efficient. This three day interactive workshop will work through live issues impacting on the Industry and on participants directly. Key benefits are individual learning, attitude and behaviour shift and diagnosis of current business and organisational issues.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=45

12th December 2006 at the EMEA in Canary Wharf, London, United Kingdom [872]
EudraVigilance: Medicinal Product Dictionary
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9416/06524.pdf

13th December 2006 - 15th December 2006 at the EMEA in Canary Wharf, London, United Kingdom [873]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9411/06525.pdf

13th December 2006 - 15th December 2006 at the Venue: Harrington Hall Hotel in London, UK [1012]
PHARMACOVIGLANCE - A Basic Training Course
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe and the USA.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=546

2007

January 2007

4th January 2007 - 5th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1013]
EUROPEAN QUALIFYING EXAM PAPER D REVISION COURSE - Answering Legal Questions
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper D is one the hardest papers of the European Qualifying Examination, particularly Part II of the paper. This course will teach the participants a clear method for approaching both parts this paper. The main stress of the course will be the answering of Part II of the paper. At the end of the course the participants will have learnt a method of answering both parts of the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=321

5th January 2007 - 6th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1027]
EUROPEAN QUALIFYING EXAM PAPER D REVISION COURSE - Answering Legal Questions
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper D is one the hardest papers of the European Qualifying Examination, particularly Part II of the paper. This course will teach the participants a clear method for approaching both parts this paper. The main stress of the course will be the answering of Part II of the paper. At the end of the course the participants will have learnt a method of answering both parts of the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=321

14th January 2007 - 18th January 2007 at the Renaissance Washington, DC Hotel in Washington, DC, USA [1036]
6th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies
The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the development and marketed use of medical products. The inherent limitations of premarketing testing and ongoing focus on the risks associated with medical product use have fostered new thinking and methods for monitoring the evolving safety profiles of marketed products throughout their life cycle. Further, while the field of risk management has added a new dimension to product safety, as an evolving discipline it requires ongoing refinement in order to enhance its applicability and value to public health. This comprehensive four-day program will address the current complexities and controversies in pharmacovigilance and risk management through discussion of the latest safety-related regulatory initiatives, description of how to optimally utilize epidemiological, clinical pharmacological and other techniques, and presentation of “state of the art” risk management strategies using illustrative examples and case studies. For more information please visit http://www.diahome.org/product/12262/07002.pdf
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/

15th January 2007 - 17th January 2007 at the The Rembrandt Hotel in London, UK [1047]
PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA - including INDIA
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in Asia including India, focusing on the practical aspects to assist regulatory activities in this region and will include the latest updates and opportunities for interactive discussion. Including China, Hong Kong, ASEAN, Brunei, Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Taiwan, Korea, Cambodia etc.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=557

17th January 2007 - 18th January 2007 at the The Rembrandt Hotel in London, UK [1029]
ISOLATORS - RISK MANAGEMENT, COMPLIANCE - ICQ (Integrated Commissioning Qualification)
With a Focus on New Technological Development & How Existing Technology May Be Effectively Applied, London . If you are concerned with either aseptic or containment isolators, at any stage from initial specification right through to production operation and maintenance, then this is the forum for you to learn more and to discuss your experience with others in the field. Integrated commissioning and validation is a relatively new concept which promises dramatic reductions in validation times, but does it work? Restricted access barrier systems are offering an alternative to isolators but what are they? Biological indicators are a perennial problem with isolators and gassing validation, what help is there? This conference brings together an international panel of specialists with practical working knowledge of the issues which challenges those working with isolator technology today.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=551

18th January 2007 - 19th January 2007 at the Hilton San Francisco Fisherman's Wharf in San Francisco, CA, USA [1085]
European Regulatory Affairs
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure.There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12446/07416%20January%20EuroReg.pdf

18th January 2007 - 19th January 2007 at the The Rembrandt Hotel in London, UK [1061]
EFFICIENT STABILITY TESTING
This conference will review the regulatory background to stability testing for both new and existing drug substances and products. The ICH guidelines will be covered from a practical point of view with guidance on interpretation and how to design the most efficient protocols to minimise resource requirements and to ensure high quality stability modules in regulatory submissions. As well as the design of stability protocols, all aspects of stability testing will be covered, including the development of robust, stability indicating analytical methods and the management of stability samples and storage facilities. Workshops are included to reinforce some of the topics.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=567

18th January 2007 - 20th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1014]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

18th January 2007 - 19th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1015]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

19th January 2007 - 20th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1026]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

21st January 2007 - 24th January 2007 at the University of Southern California in Irvine, CA, USA [1084]
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. Key Topics •Overview of FDA •Regulatory requirements for drug development and approval •Post-approval and marketing regulatory requirements and processes •Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12244/07401%20January%20Reg%20Combo%20USC.pdf

21st January 2007 - 24th January 2007 at the University of Southern California in Irvine, CA, USA [1035]
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. Key Topics Overview of FDA Regulatory requirements for drug development and approval Post-approval and marketing regulatory requirements and processes Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12244/07401%20January%20Reg%20Combo%20USC.pdf

22nd January 2007 at the The Rembrandt Hotel in London, UK [1016]
MULTI-TASKING & MANAGING MANAGERS IN THE PHARMACEUTICAL INDUSTRY
In the very challenging environment of the pharmaceutical industry, the role of administrators, support staff and secretaries has become increasingly demanding as they need to be working with multiple tasks (and sometimes their conflicting) projects, deadlines and assignments. They also need to manage managers who are frequently out of the office, and working with more than one manager. This highly stimulating and interactive course will enable participants to become more effective and enthusiastic and enhance their organisational skills which in turn will help them become more productive. They will also learn how to manage priorities and projects and how to keep things running smoothly when their Manager is away. Participants will gain practical skills that will enable them to be much more valuable and more effective than previously, thus enabling them to take on more responsibility and have greater job satisfaction.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=540

24th January 2007 - 25th January 2007 at the Washington Marriott Hotel in Washington, DC, USA [1125]
Sharing Knowledge to Improve Clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts
Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities List recognizes several joint development paths that could improve pharmaceutical productivity and reduce failure rates. These paths include: •Better understanding of prior information in making current drug development and approval decisions •Better understanding of disease through biomarkers •Application of modern bioinformatics to mine prior knowledge (e.g., NDAs) sources Oftentimes, useful prior clinical trial information that could improve drug development efficiency is lost within companies and at the FDA. This information could help us to better understand the biomarker relationship to primary disease endpoints, disease change over time, placebo effect, and drug effect on disease. These quantitative relationships can help employ biomarkers (e.g., biochemical, imaging, genomic) in dose finding, the creation of new surrogate markers, planning of effective clinical trials, and making better clinical development and regulatory decisions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12234/07005.pdf

24th January 2007 - 25th January 2007 at the The DeVere Cavendish Hotel in London, UK [1038]
EC MEDICAL DEVICE VIGILANCE SYSTEMS AND POST MARKETING SURVEILLANCE
While the pre-market approval process has been delegated by most of the Competent Authorities to the private sector, Competent Authorities have kept the responsibility for the surveillance of their market. Because of this situation, there is transfer of resource and energy to the monitoring of market including the Vigilance System within each Member State. The evaluation of incidents notified by the manufacturers and users represents a key source of information. Combined with sophisticated exchange of information between EU Member States, and also with other countries like USA, Japan, Canada or Australia, this provides a unique insight of the performance of devices in the post production phase. Full compliance with the vigilance requirements laid down in Article 10 of directive 93/42/EC is justified by the manufacturer’s legal obligations, risks associated to litigation and increasing scrutiny of Member States, but mainly by the ultimate objective of providing safe devices to patients. Manufacturers can not afford not to comply with these requirements. This conference provides a unique opportunity to meet Competent Authorities, consultants and manufacturers to understand and discuss the regulatory requirements with respect to post marketing surveillance including vigilance.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=555

24th January 2007 - 26th January 2007 at the EMEA in Canary Wharf, London, United Kingdom [1032]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12249/EV%202007%20web.pdf

24th January 2007 - 25th January 2007 at the Washington Marriott Hotel in Washington, DC, USA [1031]
Sharing Data and Models to Improve Clinical Drug Development and Regulatory Decisions
Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities List recognizes several joint development paths that could improve pharmaceutical productivity and reduce failure rates. These paths include: •Better understanding of prior information in making current drug development and approval decisions •Better understanding of disease through biomarkers •Application of modern bioinformatics to mine prior knowledge (e.g., NDAs) sources Oftentimes, useful prior clinical trial information that could improve drug development efficiency is lost within companies and at the FDA. This information could help us to better understand the biomarker relationship to primary disease endpoints, disease change over time, placebo effect, and drug effect on disease. These quantitative relationships can help employ biomarkers (e.g., biochemical, imaging, genomic) in dose finding, the creation of new surrogate markers, planning of effective clinical trials, and making better clinical development and regulatory decisions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12234/07005.pdf

24th January 2007 - 26th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1017]
DEVELOPING MEDICINES FOR COMPANION ANIMALS - A Comprehensive Introduction
The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take the participants through all the stages in the development of a veterinary medicinal product for companion animals, for which a marketing authorisation is sought in the European Union.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=510

25th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1018]
OPPOSITION AND APPEALS - THE EPO CASE LAW
This seminar will consider, drawing on case law and the speakers’ experience, the present working of opposition and appeal procedures at the European Patent Office, including recent developments. The course can be attended with Substantive Patent Law of the EPO Boards of Appeal, on 26th January. Discounts are available for attending both seminars.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=111

26th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1019]
PATENTS - THE EPO CASE LAW
This seminar will cover the main substantive aspects of European patent law as evolved by the decisions of the European Patent Office Boards of Appeal, including recent developments. It can be attended in conjunction with Opposition & Appeal Procedures at the EPO on 25th January. Discount available for attending both.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=112

26th January 2007 at the Venue: Harrington Hall Hotel in London, UK [1020]
ESSENTIAL GUIDE TO PHARMACOVIGILANCE - A one day concise overview
Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for Companies to perform various duties regarding the safety of their products to satisfy regulatory demands. Regulatory Authorities are visiting all licence holders to perform inspections on a Companies compliance to Pharmacovigilance and the visits can also include visiting marketing partners as well (even outside the EU) and the sanctions that exist for those Companies who do not look after the safety of their products are severe and which could result in licence withdrawal. This course has been designed to simply explain what Companies need to be aware of those in terms of their responsibilities and what they need to do to avoid regulatory action. Can you afford not to know?
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=477

29th January 2007 - 30th January 2007 at the Arcadia Ichigaya, 4-2-25 Kudankita Chiyoda-ku in Tokyo, Japan [1107]
DIA's 10th Annual Workshop in Japan for Clinical Data Management: Return to the Basics- Does Quality Meet "User" Requirements?
It’s the 10 year anniversary for the Clinical Data Management workshop. This anniversary, celebratory workshop promises to provide special new ideas. We encourage professionals at every level of responsibility, from beginners to experts, to participate in this annual meeting. The objectives of this annual meeting are to improve the quality of trials and to provide ideas for data management activities. However, it is easy to lose the way if people forget what their real objectives are. That’s the reason why we set this year’s main theme. This annual meeting will deliver information to attendees about the Japanese clinical data management processes, as well as provide opportunities to meet and network with colleagues in Clinical Data Management. The sessions include: •Standards, Quality level •Optimized process of data management and clinical development •Best practice of data management •Technical solutions for data managers •New technology to affect data management processes.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11589/07301.pdf

29th January 2007 at the The Rembrandt Hotel in London, UK [1060]
PERIODIC SAFETY UPDATE REPORTS
Periodic Safety Update Reports (PSURs) are a regulatory requirement in US, Europe and Japan and now other countries are beginning to request safety updates to support new submissions and renewals of marketed products. Individual requests for PSURs are a potential burden on pharmacovigilance resources. This workshop will focus on the practicalities of meeting the regulatory, scientific and public health expectations associated with the PSUR process, including EU Harmonisation of PSURs. The speakers will cover the topic from both regulatory and pharmaceutical industry perspectives and a practical session will give participants hands-on experience in dealing with some of the potential issues in producing PSURs
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=572

29th January 2007 - 31st January 2007 at the AGES Spargelfeldstrasse 191 in Vienna, Austria [1067]
EudraVigilance: Electronic Reporting of ICSRs in the EEA - Austria
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12231/Austria_January.pdf

29th January 2007 - 30th January 2007 at the The Rembrandt Hotel in London, UK [1030]
SUCCESSFUL PHARMACEUTICAL PROJECT MANAGEMENT - A highly succesful interactive course
This course has been designed to provide a thorough understanding of project management skills, both technical and interpersonal skills. It will show how to use these project management skills to gain the most benefit from them in your projects
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=221

29th January 2007 - 30th January 2007 at the Venue: Harrington Hall Hotel in London, UK [1021]
FDA APPROVAL PROCESS FOR MEDICAL DEVICES
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=529

29th January 2007 - 2nd February 2007 at the Venue: The Rembrandt Hotel in London, UK [1022]
WORKING THROUGH DRUG DEVELOPMENT - Winter School
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. this course has been designed to how how toxicology,clinical investigations and regulatory practices are joined into a continuous process. It will commence with a general introduction to the process of drug development and continue with lectures on the following aspects: Toxicological requirements, Pharmaceutical and Analytical development, Marketing and Business Development, Pharmacokinetic and Metabolic studies, Phase I and healthy volunteer work: Phase II/III - trial design and protocols, and clinical project management; Handling Safety Data in development; ending on the final day with regulatory matters including marketing applications and post-marketing activities.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=99

February 2007

4th February 2007 - 8th February 2007 at the Crowne Plaze Union Square in San Francisco, CA, [1071]
20th Annual Pharmacokinetics for Pharmaceutical Scientists
Pharmacokinetics for Pharmaceutical Scientists University of California, San Francisco School of Pharmacy • Department of Biopharmaceutical Sciences February 4–8, 2007 The Department of Biopharmaceutical Sciences, School of Pharmacy, is pleased to announce the 20th Annual fundamentals course on Pharmacokinetics for Pharmaceutical Scientists, February 4-8, 2007, in San Francisco. The course will emphasize basic principles in pharmacokinetics. Presentations will be delivered via lectures and multiple small-group workshops. The first three and one-half days of this limited enrollment course will be devoted to essential pharmacokinetic parameters and how they are employed to summarize and predict temporal relationships. The balance of the course will focus on elective topics.
Contact: Bill Karpowicz
Telephone: ; Fax:
Email: info@ucsf-pk-course.org
Website: http://www.ucsf-pk-course.org/

6th February 2007 - 9th February 2007 at the Loews Philadelphia Hotel in Philadelphia, PA, USA [877]
1987-2007 - EDM's 20th Anniversary Conference: Reconnecting the Process to the Delivery of Safe and Effective Medical Products
Over the past 20 years, the DIA EDM Conference has served as a platform for the discussion of emerging standards and processes for the creation, submission and retention of regulatory information. Within the past 2 to 3 years, there has been an increasing recognition of a broader and more complex environment that critically needs interoperability standards to create, electronically exchange and manage this ever growing array of medical and regulatory information. Being Proactively positioned and strategically aligned will require internal thought and planning to facilitate process re-engineering and re-tooling. While change is inevitable, the need for readily available current information while still ensuring data protection is essential. Traditional business roles are being remodeled and re-scoped with The convergence of disciplines and cultural change. It is essential in this complex environment to not only continuously re-analyze the business and information process, but to analyze the impact To touch points, intersections, interdependencies, and interoperability connectors all along the drug development continuum to ensure the delivery of safe and effective medical products.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11363/07003.pdf

6th February 2007 at the Harrington Hall Hotel in London, UK [1127]
PARALLEL TRADE AND THE PHARMA INDUSTRY
WHY YOU SHOULD ATTEND Parallel Trade has been a major concern to the research based industry since the late 1980's. The European Commission upholds the principle of free movement of goods. National governments maintain the right to intervene on the prices of medicines. The inevitable result is price difference and parallel trade from low-priced to high-priced countries. What is the real impact of parallel trade on the research based industry? Clearly there is a significant impact on revenue and profits with the potential that future research and development could be compromised. What responses are available to the industry? Learn the latest and hear the views of the experts concerning the present and future import of parallel trade in medicines.
Contact: Barbara McManus / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=582

6th February 2007 at the Loews Philadelphia Hotel in Philadelphia, PA, USA [1123]
Development of Clinical Study Report Training Course
Examine best practices for preparing integrated clinical study reports for pharmaceutical products. Discussion will focus on the structure and format of a clinical study report, with special attention given to the inclusion and presentation of study-specific information and data.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12548/07425%20February%20%20Devel%20of%20CSR.pdf

7th February 2007 - 8th February 2007 at the The Rembrandt Hotel in London, United Kingdom [1089]
THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role
Being an effective CRA or Clinical Trial Administrator/Coordinator is vitally important to ensure that clinical trials are carried out on time, to budget, and to comply with GCP and the EU Clinical Trial Directive. It is also important that the CRAs and clinical research support staff fulfil all the necessary regulatory requirements and follow company SOPs. Clinical Trial Support staff such as Clinical Trial Administrators/Coordinators are frequently accompanying CRAs on monitoring visits and are managing the logistics for clinical trials. In addition to CRAs, this course is also particularly relevant to support staff who are helping CRAs and/or are considering moving into a CRA role or a clinical trial project management role. This interactive course will provide you with the skills and knowledge to be a successful and effective CRA/Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include planning and preparation for setting up clinical trials, understanding the responsibilities at both the study site and the sponsor site, and how to carry out the crucial study site visits (including site selection, site initiation, ongoing monitoring and study close down). You will cover how to prepare for an audit and/or regulatory inspection including an overview of common audit and regulatory findings, and finally how to detect and manage the suspicion of fraud. How the CRA/Support staff can manage the challenges of technological advances on collecting data such as EDC will also be discussed. This comprehensive course will ensure that CRAs and Support Staff are up to date on the latest regulatory GCP requirements including the EU Clinical Trial Directive and Implementation texts, and the new GCP Directive.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=341

7th February 2007 - 8th February 2007 at the Harrington Hall Hotel in London, UK [1039]
PRACTICAL IMPLEMENTATION OF GCP IN VET FIELD STUDIES
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP. The meeting will address a typical case study where a practical approach will be made to setting up, running and monitoring clinical trials followed by an audit of these studies to satisfy the stringent requirements seen in Europe. Standard documentation utilised for recording data, performing audits and a typical protocol will be supplied for use in the company attendees' own laboratories.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=554

8th February 2007 - 9th February 2007 at the The Cafe Royal in London, UK [1040]
NASAL DRUG DELIVERY - Exploring This Rapidly Developing Area
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=552

8th February 2007 at the The Rembrandt Hotel in London, United Kingdom [1090]
OHIM ONLINE SERVICES FOR COMMUNITY TRADEMARKS AND DESIGNS
This course will give participants a complete one day teaching package, with practical examples and hands-on experience of the new online services provided by OHIM for filing and renewing community trade marks and designs, together with opposition procedures. Each participant will have the use of an online PC to help them obtain maximum benefit from the course.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=575

8th February 2007 at the The De Vere Cavendish Hotel in London, United Kingdom [1093]
ADVANCED PHARMACOKINETICS/PHARMACODYNAMICS
For some years Scientific literature has discussed building models to aid understanding of pharmacokinetic and pharmacodynamic processes that underlie drug action. However, within the drug development environment, it is only relatively recently that the prospective application of exposure response relationship characterisation has become more widespread. Climate changes with the Pharmaceutical Industry and Regulatory Agencies are driving the need for a more comprehensive adoption of these approaches.As the product of drug development is 'knowledge', and its appropriate utilisation is essential in permitting the pharmaceutical industry to meet future challenges, modelling, simulation and CATD can provide an important technical solution to 'knowledge management' strategies.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=80

8th February 2007 - 9th February 2007 at the The De Vere Cavendish Hotel in London, UK [1092]
THE US DRUG APPROVAL PROCESS
This seminar, by a US lawyer with over 25 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to FDA's procedures designed to expedite the testing and approval of new medicines and other topics of current interest and discuss the new report by the Institute of Medicine of the National Academy of Sciences of the FDA Drug Approval Process
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=574

9th February 2007 at the The Rembrandt Hotel in London, UK [1062]
A PRACTICAL INTRODUCTION TO PATENTS - Comprehensive foundation course
This one-day course has been designed to enable people to work in practice with the patent system by providing a practical introduction to basic national and international patent law. It will place patents within the wider context of intellectual property rights, outline the basic steps required to obtain a typical patent, and consider infringement and remedies. The role of patents as property and business tools will also be considered, and will conclude with a look at current developments and future proposals for reform and harmonisation of patent law worldwide.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=191

9th February 2007 at the Harrington Hall Hotel in London, UK [1063]
THE PATENT ADMINISTRATOR
This one-day interactive seminar will provide an overview of the key roles and responsibilities of Patent Administrators and Legal Assistants. The course will give participants an excellent understanding of the key activities in which they are likely to be involved and assist them in working more effectively and efficiently within their role.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=264

12th February 2007 - 13th February 2007 at the DIA in Horsham, PA, USA [1140]
Overview of Drug Development in Japan Training Course
The Japanese pharmaceutical market, with sales of $60 billion in 2005, is the second largest market comprising approximately 11% of the global market. Despite the size of this market, many multinational companies struggle to synchronize or integrate Drug development in Japan with the US/EU. As a result, there continues to be a significant lag in new drug approvals in Japan as compared to the West. There are many barriers to successful drug development in Japan and this course has been specifically designed to provide some insight into this process. Through a series of highly interactive presentations and case studies, this course will explore the Developmental requirements, regulatory environment, and commercial opportunities for medicines in Japan.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12456/07417%20February%20Overview%20of%20DD%20Japan.pdf

15th February 2007 - 16th February 2007 at the The Rembrandt Hotel in London, UK [1041]
FORMAL REQUIREMENTS FOR US PATENT APPLICATIONS - A practical course for patent administrative staff
This hands-on course covers the step-by step prosecution of patent applications before the United States Patent Office from filing through to patent issuance and beyond. A primary focus of this course will be on identifying recentUS patent law changes and explaining how they change US patent prosecution practice and strategies. Another important focus of the course will be upon the mechanics of US patent prosecution procedures, on the forms, fees and filing requirements used during each step of prosecution. Prosecution mecahnics will be reinforced through hands-on form review and completion exercises. In addition the course will identify and provide publicly available information and forms that are useful resources for US patent prosecution.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=54

19th February 2007 - 21st February 2007 at the Moller Centre in Cambridge, UK [1114]
Stability testing of Pharmaceuticals
The course will provide a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals and related products. Aspects to be covered will include the criteria for product stability, problems associated with specific product types, including biotechnology products, new technology for stability assessment, and the application and limitations of stability test procedures. UK and international regulatory aspects will be discussed, including the guidelines for stability testing within the EU, Japan and the USA introduced through the ICH (International Conference on Harmonisation). Workshop sessions will use practical examples to illustrate essential steps in the development of stability testing protocols. Sufficient time will be available for detailed discussion and questions during the lecture programme.
Contact: Susan Hughes
Telephone: 020 7572 2640; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/worldofpharmacy/events/

19th February 2007 - 22nd February 2007 at the in Barcelona, Spain [921]
The 6th Pharmaceutical Powder X-ray Diffraction Symposium
The International Centre for Diffraction Data (ICDD) is proud to present PPXRD-6 in Barcelona, Spain. This three day training on up to date issues in XRD in the pharmaceutical industry will include such topics as patent and regulatory issues, process analytical technology, Rietveld refinement, complimentary techniques and much more….Don’t miss the optional one day workshop on Characterization of Pharmaceutical Solids: Crystal Studies and XRD Applications.
Contact: Leah Mooney, Education Coordinator
Telephone: ; Fax:
Email: ppxrd@icdd.com
Website:

19th February 2007 at the Rembrandt Hotel, London in London, UK [1023]
PROJECT MANAGEMENT FOR SUPPORT STAFF
As organisations need to become more flexible, it is increasingly common for support staff to apply project management skills in their work to enable them to become more effective. To be (or become) a more senior administrator, project management skills are essential. Being a member of a project team or managing a project demands a special set of technical and people skills. It is essential to have good support staff who can understand and use a proactive project management approach to their work. Support staff who use project management skills can make a positive contribution to meeting the goals and objectives of the organisation, whilst coping with the increasing pressures and the large amount of change that is likely to be a key part of their work. This practical, interactive course has been designed to provide support staff and team members with an understanding of project management skills in order to successfully manage the projects they support.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=541

20th February 2007 - 22nd February 2007 at the New York Marriott Marquis Hotel in New York, USA [1054]
19th Annual Conference on Marketing Pharmaceuticals in a Time of Change
This program is designed both for people who are new to advertising and promotion issues, as well as those who have been involved in this area for some time. It is designed to provide practical, day-to-day guidance on what can be learned from the latest FDA enforcement actions, and how companies and their legal, regulatory, marketing, advertising and PR consultants can do their jobs better. This year’s program focuses on the key issues facing advertising and promotion today, such as enforcement, off-label promotion, training, the new physician labeling rules, state regulations, and the increasingly important role of the Office of Inspector General. This program also provides an opportunity for greater participation in break-out sessions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/

20th February 2007 - 21st February 2007 at the The Rembrandt Hotel in London, United Kingdom [1064]
EU REIMBURSEMENT FOR MEDICAL DEVICES
The reimbursement and funding of medical devices in Europe is managed according to the principle of subsidiary. This means that there is no pan European system: systems are established and decisions made at the national level and even in some countries at the regional level. Manufacturers selling their products in Europe need to understand how their products will be managed country by country. This seminar, presented by nationally based reimbursement experts from the five major European markets, will look at each country in depth and will describe the reimbursement and funding system for medical technologies and for medical procedures considering both the pubic and private sectors. There will be clear practical advice as to how to set about achieving reimbursement for medical technologies and procedures in each country. Understanding that many manufacturers want to sell their products across Europe, the speakers will draw out opportunities to compile a generic reimbursement dossier that can be customised to meet the needs of the national systems. As well as formal presentations and case studies the seminar will include many opportunities for interaction and discussion. In particular, delegates will be able to book individual time slots with the speakers to discuss issues specific to their product area and the seminar will conclude with a round table discussion in which the panel will cover questions and issues raised by the delegates.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=570

21st February 2007 - 23rd February 2007 at the EMEA in Canary Wharf, London, United Kingdom [1033]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12250/EV%202007%20web.pdf

22nd February 2007 - 23rd February 2007 at the The Rembrandt Hotel in London, UK [1042]
HOW TO USE PATENT LEGAL STATUS RECORDS & REGISTERS
This intensive, practical course will comprise a mixture of lectures, tutorials and hands-on practice with each of the free-of-charge, public services available for the major national patent offices. Each participant will be given use of an on-line PC to give them maximum hands-on experience of how to use the patent legal status records and registers effectively. Private, encrypted services will be noted but not accessed
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=251

22nd February 2007 - 23rd February 2007 at the Harrington Hall Hotel in London, United Kingdom [1094]
PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST, London
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, incuding Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=471

22nd February 2007 - 23rd February 2007 at the Hotel to be Announced in London, UK [1024]
THE REGULATION OF VETERINARY MEDICINAL PRODUCTS IN EUROPE
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: 01689 834860
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=522

23rd February 2007 at the Hotel to be Advised in London, UK [1095]
THE EPC 2000
The course will explain the major differences between the provisions of the revised EPC coming into force on or before 13 December 2007 (EPC 2000) and those of the EPC as it is currently in force. The practical significance of these changes will also be discussed. The course is directed at practitioners, trainee attorneys and senior paralegals. Basic knowledge of the EPO system is required.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=573

26th February 2007 - 28th February 2007 at the Regus Centre Romania in Bucharest, Romania [1141]
EudraVigilance: Electronic Reporting of ICSRs in the EEA 07521
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12444/PGM-Romania_07521.pdf

26th February 2007 at the Harrington Hall Hotel in London, UK [1128]
THE BORDERLINES BETWEEN COSMETICS & DRUGS
Chairman Prof. Ronald Marks, Speakers Dr.Anthony Dweck, Dr. Peter Lassoff, Jane Cole WHY YOU SHOULD ATTEND Europe, the USA and the rest of the affluent West are increasingly interested in the medicinal use of cosmetics. The reasons for this include the trends to self medication and pharmacy treatments plus the increasing numbers of individuals who present with their skin related complaints. In addition, there is a growing recognition of a pharmacological activity and clinical usefulness of many agents previously classified as cosmetics. This important meeting will address the main issues surrounding the shifting borderline between cosmetics and drugs, including the latest statutory procedures and how Industry can work within the Regulations.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=580

26th February 2007 - 27th February 2007 at the Steigenberger Hotel Metropolitan in Frankfurt, Germany [1137]
European Regulatory Affairs
The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency - Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12248/07520.pdf

28th February 2007 at the The Institute of Directors in London, UK [1121]
SPORTS LAW
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=576

March 2007

4th March 2007 - 7th March 2007 at the Hyatt Regency Islandia Hotel & Marina in San Diego, CA, USA [992]
18th Annual Workshop on Medical Communications: Medical Information, Medical Liaisons, Contact Centers
CONFERENCE HIGHLIGHTS Sunday, March 4 •Core Curriculum – in-depth discussions, case studies, roundtable discussions •Welcome Reception – casual atmosphere for meeting and networking with conference attendees Monday, March 5 •Our changing healthcare landscape and implications for Medical Communications •Establishing the value proposition of pharmaceuticals •Breakout sessions on topics pertinent to field- and headquarters-based medical information practice •Evening reception featuring Resident Poster Presentations Tuesday, March 6 •Application of Knowledge Management in Medical Communications •Podium and Poster Pearls •Recurring breakout sessions regarding medical writing, corporate coordination of external communications, medical information support of investigational and legacy products, customer service skills, and more •Sessions relevant for Field Based Medical on identifying thought leaders and scientific hot topics Wednesday, March 7 •Two important sessions related to regulatory and legal hot topics in Medical Communications.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11921/07006.pdf

5th March 2007 at the Courtyard Philadelphia Willow Grove in Willow Grove, PA, USA [1131]
Overview of Drug Development Training Course
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA. The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12467/07418%20March%20%20Overview%20DD.pdf

5th March 2007 - 8th March 2007 at the Hyatt Regency Philadelphia at Penn's Landing in Philadelphia, PA, USA [1091]
The Leadership Experience
THE LEADERSHIP EXPERIENCE is a 3 1/2-day session in which participants, working in a group, assume senior management roles. They analyze information, make decisions, and deal with the consequences of their decisions. There is special emphasis on the skills required to establish cooperation, diagnose and correct dysfunctional groups, and combine the skills of multiple people to accomplish what cannot be done alone. This is a VERY intensive program designed for those who are serious about improving their leadership skills.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12458/07406%20march.pdf

6th March 2007 - 7th March 2007 at the The Rembrandt Hotel in London, UK [1048]
EXCIPIENTS
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=558

7th March 2007 - 9th March 2007 at the Hotel Ambassador in Barcelona, Spain [1096]
SUCCESSFUL MEDICAL WRITING: In Barcelona
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard. See also the European Medical Writers Association (EMWA) website at www.emwa.org
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=56

7th March 2007 - 9th March 2007 at the Raffles City in Singapore, singapore [760]
6th International Symposium on Antimicrobial Agents and Resistance (ISAAR 2007)
Singapore is proud to be the first country outside Korea to host the International Symposium on Antimicrobial Agents and Resistance (ISAAR). We have lined up a list of eminent speakers from all over the world, and have put together a varied scientific programme. The bane of antimicrobial resistance has been felt worldwide and the need to find solutions has received the attention not only of clinicians and academics but also government and other policy-makers. Hence our theme - Searching for Solutions. Come to Singapore - a vibrant global city, where the coming together of East and West is a daily affair. Come and listen to possible solutions to this problem of antibiotic resistance that plague us and our patients on a daily basis. We will have symposia featuring vaccines, diagnostic techniques, new antibiotics, and countrywide initiatives to combat the resistance problem. Bring along your data and share them with friends and colleagues through our poster sessions. Bring along your families and enjoy Singapore.
Contact: Susan Chung
Telephone: ; Fax:
Email: isaar@ansorp.org
Website: http://www.isaar.org/

8th March 2007 - 9th March 2007 at the Venue: The Rembrandt Hotel in London, UK [1025]
US REIMBURSEMENT OF MEDICAL DEVICES
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=512

9th March 2007 at the The Rembrandt Hotel in London, UK [1065]
INTRODUCTION TO CONTRACTS
This practical seminar has been designed for administrators, secretarial and other support staff to provide an overview of how contracts and other legally-binding documents are prepared, agreed, implemented and managed. Specific topics to be considered will include how contracts are structured, worded, negotiated, executed, implemented, administered, interpreted, amended and terminated, and how disputes over contracts are handled. Participants will be given the opportunity to complete practical exercises on dealing with contractual documentation
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=571

12th March 2007 - 14th March 2007 at the Royal Pharmaceutical Society in London, UK [1118]
Twelfth Arden House European conference
The parenteral route remains an important route of delivery of medicines for the pharmaceutical industry for both small molecules and, increasingly, biologics. This conference will address the current best practices, challenges and trends associated with the development, manufacture and registration of parenteral products. Topics This Conference will focus on the following topics: • Top issues for parenteral dosage form development • Risk-based approach to development and manufacture • Development and manufacture of biologicals • Facilities, validation and plant design • Packaging and devices • Emerging new technologies • Regulatory trends The Conference will provide an intensive course of study for pharmaceutical scientists working in all aspects of the research and development, production, registration and the licensing of parenteral dosage forms. Who should attend? Managers and scientists with responsibilities for all aspects from R & D, product development, manufacture, QA/QC, regulatory affairs and from the regulatory agencies.
Contact: Susan Hughes
Telephone: 020 7572 2640; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/worldofpharmacy/events/

13th March 2007 at the Hotel to be announced. in London, UK [1049]
PRODUCT QUALITY REVIEW
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=559

18th March 2007 - 20th March 2007 at the Hilton in the Walt Disney World Resort in Lake Buena Vista, FL, USA [944]
22nd Annual DIA CLINICAL DATA MANAGEMENT Symposium and Exhibition Integration Across the Clinical Trial Continuum
This annual meeting will deliver the latest information to attendees about the evolving clinical data management function, as well as provide opportunities to meet and network with colleagues in the industry. The sessions will highlight and address changes in the overall clinical development environment due to new approaches to data management and new technologies supporting data management. The result is a paradigm shift of the role of data management in a changing industry.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11436/07004.pdf

19th March 2007 - 21st March 2007 at the Hilton in the Walt Disney World Resort in Lake Buena Vista, FL, USA [1057]
Clinical Data Management
This course is designed for data management professionals who have less than one year of pharmaceutical or related industry experience. It combines lectures and in-depth discussions with hands-on exercises relating to clinical data management activities in the drug development process, including the roles of research team members. Key Topics •Drug development process •Clinical data management •Role of data management in clinical research •Regulatory agencies and guidelines and their impact on clinical data management.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12245/07402.pdf

20th March 2007 at the EMEA in Canary Wharf, London, United Kingdom [1068]
EudraVigilance: Medicinal Product Dictionary
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC). This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorised medicinal product data in the EVMPD by the Sponsor or the MAH. Participants will receive a training certificate that will allow them to register with EudraVigilance and to enter and maintain IMP and authorized medicinal product data in the EVMPD.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12371/EVMPD%202007web.pdf

21st March 2007 - 23rd March 2007 at the The Rembrandt Hotel in London, UK [1066]
ADVANCED PHARMACOVIGILANCE - A 3 Day Advanced Level Course
This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. It will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company. The group interactive sessions will highlight everyday situations that are going to be requiring thought and application of the legislation in order to generate the necessary compliance that will satisfy regulatory inspections. As well as expanding your global safety knowledge, this course will enable you to enhance your team’s capabilities and compliance in terms of both the regulations and your Company’s expectations. This will provide you with an excellent platform to build and maintain a quality Pharmacovigilance Department/Organisation ready for any Pharmacovigilance Inspection.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=501

21st March 2007 - 23rd March 2007 at the Hotel to be Announced in London, UK [1050]
EUROPEAN PHARMACEUTICAL REGULATORY PROCEDURES AND STANDARDS
Major Regulatory Essentials in 3 Days Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=561

21st March 2007 - 23rd March 2007 at the EMEA in Canary Wharf, London, United Kingdom [1070]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12350/EV%202007%20web.pdf

22nd March 2007 - 23rd March 2007 at the The Cafe Royal in London, UK [1043]
NEEDLE-FREE, AUTO-AND PEN INJECTORS - Advances in Injection Technology
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=553

23rd March 2007 at the The Rembrandt Hotel in London, UK [1129]
INTRODUCTORY OVERVIEW OF THE PHARMA INDUSTRY New
AIMS AND OBJECTIVES This comprehensive programme will give participants an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development and finally marketing. It will provide a step by step understanding of the main areas of drug development and will discuss the roles and responsibilities of key staff involved. Participants will be given a comprehensive glossary of the most commonly used industry terms which will be an invaluable reference to help them get to grips with the technical terminology and jargon. By giving delegates a broader understanding of the pharmaceutical industry as a whole, the seminar will help them become more effective, professional and motivated in their daily work.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=581

26th March 2007 - 27th March 2007 at the Park Hyatt Philadelphia at the Bellevue in Philadelphia, PA, USA [1109]
Regulatory I Training Course
The course will focus on drug and well-characterized biological products and not the regulatory process for devices or generic products. This course describes the regulatory background of the IND and provides an overview of preparing an IND for submission to the FDA. •Overview of FDA •Regulatory requirements for drug Development •Roles and responsibilities of FDA •Pertinent regulatory processes and Forms (investigational new drug Applications [inds], etc.).
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12470/07419%20March%20Reg%201.pdf

26th March 2007 - 28th March 2007 at the Austria Center Vienna in Vienna, Austria [1138]
19th Annual EuroMeeting
DIA's 19th Annual EuroMeeting is global in scope, attracting more than 2,600 industry professionals from over 50 countries. Europe's annual flagship event offers timely and relevant session topics, continuing education, networking opportunities, and access to a sold-out exhibit hall. This one-of-a-kind meeting brings together professionals from the biopharmaceutical industry, contract service organizations, academic research centers, and regulatory agencies. This convergence affords attendees the opportunity to network with professional colleagues from around the world. With more than 130 sessions in 24 tracks, the annual event covers a variety of cross-disciplinary topics—from regulatory compliance to information technology to project management and outsourcing.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/DIAHome/FlagshipMeetings/Home.aspx?meetingid=10610

28th March 2007 - 29th March 2007 at the Radisson SAS Hotel in Nice, France [1051]
BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
The purpose of this seminar is to provide non-biotechnologists with the basic theory to understand the principles, techniques and potentials of biotechnology. Biotechnology is the use of biological processes to provide useful products, services and environmental management. Biotechnology combines disciplines such as molecular biology, biochemistry, chemistry, microbiology, chemical engineering and computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=562

29th March 2007 - 30th March 2007 at the The Rembrandt Hotel in London, UK [1122]
DIABETES METABOLIC CARDIOLOGY AND OBESITY
In recent years there has been considerable interest in the development of new anti-diabetic and obesity drugs. This stems from the enormous global increase in the prevalence of diabetes and obesity and the resulting economic and public health sequelae. The association of diabetes and obesity, together with other commonly found risk factors (or Cardiometabolic Risk factors) is called the metabolic syndrome. Current therapies, although usually effective in the short-term at addressing glycaemic and weight control, do not have durable effects, nor do they influence the associated cardiovascular morbidity and mortality. The cardiovascular complications resulting from the metabolic syndrome have stimulated a new branch of cardiology, termed metabolic cardiology. This unique seminar will bring together leading authorities who will provide an overview of our current understanding of diabetes (type 1 and type 2) and its therapies. However, as type 2 is the most common diagnosis the programme will particularly focus on this area. Presentations outlining novel developments in the treatment of diabetes together with the pharmacoeconomic and regulatory considerations will be followed by discussion and feedback from the delegates. Similar presentations and discussions will follow for obesity and metabolic cardiology. Attendance at this seminar will enhance your ability to understand diabetes, obesity and metabolic cardiology in the present, provide an update on the pharmacoeconomic and regulatory requirements and give an important glimpse into the future of the metabolic syndrome in all its various facets.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=569

30th March 2007 at the Radisson SAS Hotel in Nice, France [1052]
BIOPHARMACEUTICAL PRODUCT DEVELOPMENT - Research to Licence - For the Non-Biotechnologist
The purpose of this one day seminar is to build on the learning from the Basic Course: Biotechnology for the Non-Biotechnologist' and will use case studies to discuss strategies for the development of biopharmaceutical products from research to licence. Therefore, a basic understanding of biotechnology will be assumed and attendance of the Basic Course: 'Biotechnology for the Non-Biotechnologists' is recommended
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=563

April 2007

15th April 2007 - 19th April 2007 at the Club Amigo Varadero Hotel in Varadero, Cuba [1037]
NeisseriaVaccines2007. International Workshop on Neisseria Vaccines
The International Workshop on Neisseria Vaccines is organized by Cuban Society for Immunology (CSI) and Latin American Association of Immunology (ALAI) to discuss update aspects concerning to Neisseria Vaccines, particularly human vaccines. The Keynotes Address, Interactive Workshops, and Poster Exhibits will give an unique opportunity for discussion and cooperation to all Colleagues from Academia, Industry, Governmental Services, and Research Institutes who are interested in sharing last experiences in these field. We look forward to the great opportunity of welcoming you warmly at our International Workshop on Neisseria Vaccines that will be help in a beautiful Cuban beach, Varadero which also permit to takes some holidays with your family. Concepci?n Campa President NeisseriaVaccines 2007 Oliver P?rez Co-President NeisseriaVaccines 2007 President of Cuban Society for Immunology
Contact: Osmir Cabrera, PhD Secretary NeisseriaVaccines2007 27 Ave. No. 19805, La Lisa, A.P. 16017, Cod. 11600. Havana. Cuba.
Telephone: 53(7) 271 6911 or 271 6932; Fax:
Email: neisseriavaccines@finlay.edu.cu
Website: http://www.sci.sld.cu/neisseria/neisseria.htm

16th April 2007 - 18th April 2007 at the Park Hyatt Philadelphia at the Bellevue Broad and Walnut Streets in Philadelphia, PA, USA [1108]
Drug Safety Surveillance Training Course
This course is designed to provide an overview of US and international safety surveillance, including the role of epidemiology and risk management, from both industry and FDA perspectives. This overview is not a “how to” course in completing adverse event forms for regulatory reporting. KEY TOPICS The role of epidemiology in safety Surveillance. Domestic and international safety Surveillance. Regulatory and industry perspectives On safety surveillance and Epidemiology.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12473/07409%20April%20DSS.pdf

16th April 2007 - 17th April 2007 at the Park Hyatt Philadelphia at the Bellevue in Philadelphia, PA, USA [1110]
Clinical Statistics for Nonstatisticians Training Course
This course is designed to be an introduction of basic statistical concepts fundamental to clinical research, for professionals who have regular exposure to statistics either through studies or professional experience. The material is roughly equivalent to an introductory statistics course. While it includes a few formulae for individuals who are interested in computational details, the course emphasizes the application of statistical concepts to clinical investigation. Key Topics: •Basic statistical principles Pertinent to clinical research.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12484/07408%20April%20Clinical%20Stats.pdf

16th April 2007 - 18th April 2007 at the Corinthia Grand Hotel Royal in Budapest, Hungary [1132]
8th International Workshop on Clinical Pharmacology of HIV Therapy
An abstract driven workshop with invited lectures, oral abstract presentations, roundtables and poster sessions. On line registration is open as from 15 November 2006. Deadline abstract submission is March 5, 2007
Contact: Jo-Els van der Woude
Telephone: +31 30 230 7147; Fax: +31 30 230 7148
Email: jo-els.vanderwoude@vironet.com
Website: http://www.virology-education.com/

19th April 2007 - 20th April 2007 at the The Rembrandt Hotel in London, UK [1097]
BASIC PCT FORMALITIES COURSE - For Patent Administrators and Formalities Staff
The purpose of this seminar is to inform the participants how to prepare an international filing under the PCT and how subsequently to monitor the consecutive procedural steps, time-limits and payment of fees under the PCT internaational phase, in designated and elected states.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=100

23rd April 2007 - 26th April 2007 at the West Chester University Business Technology Center, WCU Graduate Business Center 1160 McDermott D in West Chester, PA, USA [1106]
Regulatory Affairs: Part I: The IND Phase & Part II: The CTD/NDA Phase
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. KEY TOPICS •Overview of FDA. •Regulatory requirements for drug development and approval. •Post approval and marketing regulatory requirements and processes. •Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12471/07411%20April%20Reg%20Combo%20wcu.pdf

25th April 2007 - 27th April 2007 at the EMEA in Canary Wharf, London, United Kingdom [1069]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12352/EV%202007%20web.pdf

26th April 2007 - 27th April 2007 at the Radisson SAS Hotel in Nice, France [1098]
IMPURITIES, IMPURITIES - Chemical, Pharma., Pharmacopoeial, Biological, Microbiological, Licensing, GMP - In Nice, France
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=564

30th April 2007 - 1st May 2007 at the DIA in Horsham, PA, USA [1112]
European Regulatory Affairs Training Course: An In-Depth Review of Registration Procedures in the European Union
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12487/07420%20April%20Euro%20Reg.pdf

May 2007

7th May 2007 - 9th May 2007 at the Park Hyatt Philadelphia at the Bellevue in Philadelphia, PA, USA [1105]
Advanced Topics in Clinical Research/Drug Development
This course reviews the drug development process for new therapeutic agents and the management of clinical programs through interactive lecture and hands-on workshops. Topics addressed include product development plans, clinical trial process, and quality concepts. KEY TOPICS •Product development plan: target product profile, multinational studies and industry challenges. •Clinical trial processes: protocol development, data collection methods, informed consent challenges, study reports and NDA/CTD. •Quality concepts: site management and auditing.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12317/07404%20May.pdf

23rd May 2007 - 25th May 2007 at the EMEA in Canary Wharf, London, United Kingdom [1073]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12353/EV%202007%20web.pdf

27th May 2007 - 29th May 2007 at the N?rnbergMesse GmbH Projektleitung TechnoPharm 2004 Messezentrum D-90471 N?rnberg in N?rnberg, Germany [738]
TechnoPharm 2007

Contact: Kerstin Steger
Telephone: +49 (0) 9 11.86 06-83 23; Fax: +49 (0) 9 11.86 06-8
Email: kerstin.steger@nuernbergmesse.de
Website: http://www.drugs-zone.com/technopharm_2007-d-266.html

31st May 2007 - 4th June 2007 at the Shanghai in Shanghai, China [1103]
The 5th Anniversary of International Drug Discovery Science and Technology
Up to 200 presentations on the emerging trend of Drug Discovery last year from world leading scientists, executives, PI, investors, and regulatory personnel. Over 100 exhibitions of cutting edge technologies, new products and corporation showcases. To enjoy network opportunities with 2000+ attendees. To meet directly with decision makers to learn how to outsourcing R & D in China from early to late stages of drug discovery. To learn the successful experiences on how to do good business on R &D for your Drug Discovery program in China from overseas giant pharmas and startup companies, Full investment, CRO verse FTE. Talent search by interactions with young scientists through poster sessions.
Contact: Annie Sun
Telephone: 0086-411-84799479; Fax: 0086-411-84799629
Email: annie@iddst.com
Website: http://www.iddst.com/

June 2007

1st June 2007 at the Radisson SAS Hotel in Nice, France [1099]
THE EU PHARMACEUTICAL DOSSIER
CTD MODULES 2.3 and 3, Nice, France Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=566

2nd June 2007 - 5th June 2007 at the Westin Ottawa in Ottawa, ON, Canada [954]
Canadian Pharmacists Association 95th Annual National Conference for Canadian pharmacists
3.5 days of CE, networking, a large trade show, social events and over 600 pharmacists and other health care leaders from across Canada. A trade show of over 75 vendors from Canada and the US. Approximately 10 CEUs (or more). Exhibit & sponsorship opportunities available.
Contact: Nancy Coll, CMP National Conference & Events Manager
Telephone: 613-523-7877 ext. 201; Fax:
Email: meetings@pharmacists.ca
Website: http://www.pharmacists.ca/

7th June 2007 - 9th June 2007 at the Hotel Novotel Paris Tour Eiffel in Paris, France [1136]
3rd International Workshop on HIV and Hepatitis Co infection
An abstract driven workshop with invited lectures, oral and poster abstract presentations, clinical case management sessions and roundtables. On line registration is open from 15 February 2007. Deadline of abstract submission is 30 April 2007.
Contact: Jo-Els van der Woude
Telephone: +31 30 230 7147; Fax: +31 30 230 7148
Email: jo-els.vanderwoude@vironet.com
Website: http://www.virology-education.com/

11th June 2007 - 15th June 2007 at the The Rembrandt Hotel in London, UK [1100]
THE PATENT SUMMER SCHOOL - A comprehensive, residential course for non-lawyers
This residential course, designed for non-attorneys working in the patent profession, will give a comprehensive overview of the world of patents, including some practical illustrations. It will outline the basic concepts of intellectual property and explain the roles and responsibilities of those directly involved, whether in-house or outside counsel. It will provide a basic understanding of the various international patent systems and major theatres of juristiction, and a representative from the European Patent Office will explain procedures within the EPO and PCT. The principles of litigation in the three major patent superpowers, Europe, USA and Asia will be explained, and advice given on organisation, support systems and the importance of patent research and information.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=449

17th June 2007 - 21st June 2007 at the Georgia World Congress Center in Atlanta,GA, USA [881]
43rd DIA Annual Meeting
The DIA Annual Meeting is the "event to attend" each year for biotechnology, pharmaceutical, and regulatory professionals. No other industry meeting of its kind can rival the breadth and depth of experience that this meeting delivers, with 28 content-area tracks and 300 sessions, and presentations geared to attendees of all experience levels. The DIA Annual Meeting, above all others, offers valuable professional cross-functional learning, networking experiences, and continuing education credits for attending tutorials and sessions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11362/07001.pdf

26th June 2007 at the EMEA in Canary Wharf, London, United Kingdom [1072]
EudraVigilance: Medicinal Product Dictionary
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC). This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorised medicinal product data in the EVMPD by the Sponsor or the MAH. Participants will receive a training certificate that will allow them to register with EudraVigilance and to enter and maintain IMP and authorized medicinal product data in the EVMPD.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12372/EVMPD%202007web.pdf

27th June 2007 - 29th June 2007 at the University of Leiden, The Netherlands in Leiden, The Netherlands [1055]
The 11th International Congress "PHYTOPHARM 2007"
The scientific program of the 11th annual Congress PHYTOPHARM 2007 is consists of plenary lectures, oral communications and 8 parallel symposia: - Modern technologies in design of natural preparations and cosmeceutics - Dietary food supplements - Medicinal plants and their utilization - Modern aspects of phytotherapy - Problems of standardization and analysis of natural preparations - Systems biology and medicinal plants - Experimental study of natural preparations and cosmeceutics - Food and health
Contact: Prof. Valery Makarov Prof. Robert Verpoorte
Telephone: +7-812-3225605, +31(0)71 5274528; Fax: +7-812-3225605
Email: phyto2007@mail.ru
Website: http://www.adaptogen.ru/phyto2007.html

27th June 2007 - 29th June 2007 at the Cavalieri Hilton Hotel, Rome. in ROME, Italy [941]
Biopharmaceutical Conference in Europe
Around the globe, healthcare is at or near the top of every policy and economic agenda. Cost, access and innovation dominate the public debate. This increased attention has focused a new degree of scrutiny on business practices in the life sciences and pharmaceutical industries and will impact everything from how the industry accesses capital, to deal terms, to the nature of innovation itself. At this year's Biopharmaceutical Conference in Europe, we invite you to join your colleagues to discuss how these and other issues are changing our businesses and how we can best respond in order to continue to bring healthcare innovation to the consumers of the world. Our conference program offers formal keynote presentations as well as lively panel discussions which encourage audience interaction. A unique factor of this conference is that no advertorial presentations are given as part of the conference program. This is an exclusive 'by invitation only' event, which provides a unique setting for like-minded individuals, at the most senior level to meet and explore new business opportunities in a relaxed, informal setting away from day to day business distractions. The conference prohibits exhibitors, general company presentations, uninvited sales pitches, or intrusion from service providers, or the press.
Contact: Jo Sharp
Telephone: +44 845 4900156; Fax: +44 845 4900158 (Uni
Email: jo.sharp@biopharmconference.com
Website: http://www.pharmamedics.com/

27th June 2007 - 29th June 2007 at the EMEA in Canary Wharf, London, United Kingdom [1075]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12354/EV%202007%20web.pdf

July 2007

11th July 2007 - 13th July 2007 at the All Nations Centre in Cardiff, United Kingdom [1101]
STRATUM CORNEUM V - In Association with the ISBS
THIS CONFERENCE IS EVENT MANAGED BY MANAGEMENT FORUM LTD To register online click the REGISTER FOR THIS EVENT button on the right of this page If you wish to attend the Conference Dinner(additional fee applicable) please indicate this in the Comments box. For general information on this event please visit www.stratumcorneum2007.com
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=515

25th July 2007 - 27th July 2007 at the EMEA in Canary Wharf, London, United Kingdom [1076]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12364/EV%202007%20web.pdf

August 2007

6th August 2007 - 9th August 2007 at the Massachusetts College of Pharmacy in Boston, MA, USA [1124]
Regulatory Affairs Training Course: Part I and II
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. KEY TOPICS •Overview of FDA. •Regulatory requirements for drug development and approval. •Post approval and marketing Regulatory requirements and processes •Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12589/07415%20August%20Reg%20Combo%20MCPHS.pdf

20th August 2007 at the Hyatt Regency Princeton in Princeton, NJ, USA [1111]
Overview of Drug Development Training Course
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA. The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines. Key topics •How the pharmaceutical industry Identifies new products and brings them to market. •Contributions of key groups within the company and how they interact. •FDA and regulation of the industry.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12482/07405%20August%20Overview%20DD.pdf

22nd August 2007 - 24th August 2007 at the EMEA in Canary Wharf, London, United Kingdom [1077]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12365/EV%202007%20web.pdf

27th August 2007 at the Doubletree Hotel O'Hare Rosemont in Rosemont, IL, USA [1126]
European Regulatory Affairs Training Course
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection. KEY TOPICS •Centralized, mutual recognition and national registration procedures in the EU. •Official regulatory policies and other issues pertinent to successful EU regulatory strategy. •EU regulatory strategy pertinent to commercial. Business and licensing arrangements. •Trademarks and patents. •Medical devices. •Clinical trial directive. •Legal status and switching.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12588/07429%20August%20Euro%20Reg.pdf

September 2007

9th September 2007 - 11th September 2007 at the The Palace Hotel in San Francisco, CA, USA [687]
36th Annual Meeting of the American College of Clinical Pharmacology
TBA
Contact: Susan Ulrich, R.Ph., Executive Director
Telephone: 315-768-6117; Fax: 315-768-6119
Email: ACCP1SSU@AOL.com
Website: http://www.ACCP1.org/

18th September 2007 at the EMEA in Canary Wharf, London, United Kingdom [1079]
EudraVigilance: Medicinal Product Dictionary
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC). This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorised medicinal product data in the EVMPD by the Sponsor or the MAH. Participants will receive a training certificate that will allow them to register with EudraVigilance and to enter and maintain IMP and authorized medicinal product data in the EVMPD.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12374/EVMPD%202007web.pdf

19th September 2007 - 21st September 2007 at the EMEA in Canary Wharf, London, United Kingdom [1080]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12366/EV%202007%20web.pdf

24th September 2007 - 25th September 2007 at the DIA in Horsham, PA, USA [1139]
Overview of Drug Development in Japan Training Course
The Japanese pharmaceutical market, with sales of $60 billion in 2005, is the second largest market comprising approximately 11% of the global market. Despite the size of this market, many multinational companies struggle to synchronize or integrate drug development in Japan with the US/EU. As a result, there continues to be a significant lag in new drug approvals in Japan as compared to the West. There are many barriers to successful drug development in Japan and this course has been specifically designed to provide some insight into this process. Through a series of highly interactive presentations and case studies, this course will explore the developmental requirements, regulatory environment, and commercial opportunities for medicines in Japan.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12469/07423%20September%20Overview%20of%20DD%20Japan.pdf

27th September 2007 - 30th September 2007 at the Renaissance Portsmouth Hotel in Portsmouth, Virginia, [942]
The 16th Annual Pediatric Pharmacy Conference

Contact: Matthew Helms
Telephone: 901-380-3617 (ext. 202); Fax:
Email: matthew.helms@ppag.org
Website: http://www.pharmamedics.com/

October 2007

11th October 2007 - 12th October 2007 at the The Rembrandt Hotel in London, UK [1102]
ANNUAL CONFERENCE FOR SENIOR PATENT ADMINISTRATORS - The 6th Annual Conference
Invaluable and successful annual forum where patent administrators can obtain the latest formalities information from the EPO and WIPO, together with an update on USPTO matters, and other issues of importance. Plenty of discussion time allowed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=488

17th October 2007 - 19th October 2007 at the EMEA in Canary Wharf, London, United Kingdom [1081]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12367/EV%202007%20web.pdf

November 2007

5th November 2007 at the Park Hyatt Philadelphia at the Bellevue in Philadelphia, PA, USA [1119]
Overview of Drug Development Training Course
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA. The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12481/07403%20November%20Overview%20DD.pdf

5th November 2007 at the Park Hyatt Philadelphia at the Bellevue in Philadelphia, PA, USA [1120]
Regulatory Affairs: Part I : The IND Phase & Part II: The CTD/NDA Phase
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. KEY TOPICS •Overview of FDA. •Regulatory requirements for drug development and approval. •Postapproval and marketing Regulatory requirements and processes. •Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12474/07412%20November%20Reg%20Combo%20Phila.pdf

5th November 2007 - 6th November 2007 at the Washington Marriott Hotel 1221 22nd Street NW in Washington, DC, USA [1104]
European Regulatory Affairs: An In-Depth Review of Registration Procedures in the European Union
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12454/07407%20November%20Euro%20Reg.pdf

14th November 2007 - 16th November 2007 at the EMEA in Canary Wharf, London, United Kingdom [1086]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12368/EV%202007%20web.pdf

December 2007

12th December 2007 - 14th December 2007 at the EMEA in Canary Wharf, London, United Kingdom [1087]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12369/EV%202007%20web.pdf

2008

July 2008

27th July 2008 - 1st August 2008 at the Qu?bec City Convention Centre in Qu?bec City, Canada [1078]
The IXth World Conference on Clinical Pharmacology and Therapeutics, CPT2008
The purpose of CPT2008 is to congregate recognized international experts, in all areas of clinical pharmacology, to allow open discussions on the advances of drug research and utilization. To ensure an excellent and diverse program, and cover the interests of pharmacologists, and clinical pharmacologist worldwide, the Scientific Program Committee includes distinguished scientists from most areas of the world.
Contact: Marie Lanouette, Conference Manager
Telephone: 613-993-0414; Fax: 613-993-7250
Email: cpt2008@nrc-cnrc.gc.ca
Website: http://www.cpt2008.org/