Institute for International Research

Wednesday, May 21, 2008

1. What are the implications of the FDA Amendments Act for how risk management is conducted in today’s pharmaceutical companies?
2. How will lifecycle management strategies for identifying and mitigating risk early on contribute to your overall risk management plan?
3. How has the media contributed to the visibility of drug safety in the United States, and how has this visibility affected the way we do business?
4. How can you devise a suitable risk management plan for use on a global level?

Participate in this discussion and be part of determining the future of how the industry deals with the changing regulations being placed on your company now. Hear the views of your peers and work together at potential actions and solutions.

This Exclusive Full Day Executive Task Force is limited to pharmaceutical company participants ONLY.

Task Force Moderator:
Christopher-Paul Milne, DVM, MPH, JD, Associate Director, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Industry Peer Facilitators:
Carmen Bozic, Vice President of Drug Safety and Risk Management, BIOGEN IDEC

Paul Coplan, Sc.D., MBA, MPH,  Senior Director, Risk Management, Global Safety Surveillance, Epidemiology and Labeling, WYETH RESEARCH

John Ferguson, Vice President Global Head of Pharmacovigilence and Medical Safety, NOVARTIS

David Haddox, DDS, MD, Vice President, Risk Management and Health Policy, PURDUE PHARMACEUTICALS

Mary Frances Schubert, Director in Clinical Risk Management and Safety Surveillance, MERCK

Issues to be Discussed:
I. Latest Regulatory Information
II. Developing a Risk Management System
III. Lifecycle Management Approach to Drug Safety
IV. Balancing the Benefi t/Risk Ratio
V. Global Risk Minimization

In Collaboration With:

PharmaNet Development Group

Task Force meets from 9:00am - 5:00pm