Registration and Breakfast

Welcome and Introduction
Kathy Granger, PhD, The New York Academy of Sciences

Keynote Address

The Regulatory Decision-Maker’s Perspective – What is the Regulator’s Decision Context?
Janet Woodcock, MD, FDA

SESSION I: Regulator's Perspective on Risk-Benefit Decisions

John Jenkins, MD, FDA

Hans-Georg Eichler, MD, European Medicines Agency

Robyn Lim, PhD, Health Canada

Coffee Break

SESSION II: Making the Tough Calls: Current Approach and Case Studies

Robert Temple, MD, FDA

Bruno Flamion, MD, PhD, EMEA

Paul Coplan, Wyeth Pharmaceuticals

Larry Phillips, PhD, London School of Economics

Lunch

SESSION III: Patient and Provider Perspectives on Specific Disease Areas

Panel discussion with FDA therapeutic division directors to speak about their particular disease areas (60 minutes)with commentary from patient advocates

Coffee Break

SESSION IV: Decision and Risk Communication

Baruch Fischhoff, PhD, Carnegie Mellon University

Panel Discussion – Future Directions

Closing Remarks

Meeting Concludes