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Risk Management Plans Ten Years On: Where Are We Now and Where Are We Going?
Session Chair(s)
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
ICH E2E on pharmacovigilance planning reached step four in 2004. Since then risk management has become a key part of licensing applications in many countries. Experts will discuss evolution over the last ten years and speculate on future developments.
Learning Objective : Discuss how risk management plans have evolved in the last 10 years; Explain opinions from regulatory, industry and contract research on how they will evolve in the future; Identify the key issues to help your organization plan for the future.
Speaker(s)
Industry Perspective
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Consultant, United Kingdom
Strategy
FDA Perspective
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Japan Perspective
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
Senior Vice President
Industry Perspective
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
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