Pharmaceutical Risk Management
March 17 – 18, 2005 Philadelphia, PA
Visit the conference website for more information and to register.
Based on overwhelming feedback and specific requests by the industry, CBI is convening a conference focused toward the current industry headlines on Pharmaceutical Risk Management. As the market and the public continue to grapple with what has been happening in the industry, and what it means for drug safety, this Forum provides specific, actionable strategies for overcoming challenges, preventing unnecessary risk and minimizing exposure to massive product liability lawsuits
The Forum Features:
- A Keynote Address by the U.S. Food and Drug Administration
- Two days of focused discussion, providing exclusive and timely coverage on Risk Management and Safety concerns impacting the industry
- 6 case studies on current risk management programs
Hear 12 Industry Perspectives
- H. Michael Arrighi, Ph.D., Director, Epidemiology, Wyeth Research
- Mariette Boerstoel-Streefland, Vice President, Drug Safety, Organon Inc.
- John Ferguson, Vice President, Drug Safety, Biogen
- Howard Fingert, M.D., Senior Director, Safety and Risk Management, Pfizer Inc
- Glenn Gormley, Vice President, Clinical Development, AstraZeneca
- Haley J Kaplowitz, Ph.D., Director, Pharmacovigilance and Epidemiology, Allergan, Inc.
- Eleanor S. Segal, M.D., Vice President and Head, Global Drug Safety, Actelion Pharmaceuticals
- Neha Sheth, Director, Risk Management, Pfizer Inc
- Susan Ackermann Shiff, Ph.D., Global Head, Risk Management, Drug Safety Risk Management, Hoffmann La-Roche
- Sebastian Sorsaburu, M.D., Medical Advisor, Global Product Safety Neuroscience, Eli Lilly and Company
- John Talian, Ph.D., Global Head, Regulatory Intelligence, Drug Regulatory Affairs, Hoffmann La-Roche Inc.
- Jerome Zeldis, M.D., Ph.D., Chief Medical Officer, Vice President, Medical Affairs, Celgene Corporation
SOME OF THE TOPICS TO BE ADDRESSED INCLUDE:
- Quantitative and qualitative approaches to benefit-risk assessment
- Understanding the importance of signal detection in risk management
- Assessment of pre-marketing risk management
- Specific methods for evaluating the success of risk management tools, including surveys, cognitive testing, patient care databases and systems databases
- Considerations for pro-active risk assessment plans