DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

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EMA-FDA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

Session Chair(s)

Peter Richard Arlett, MD, FFPM, FRCP

Head Data Analytics and Methods Task Force

European Medicines Agency, Netherlands

This session will cover the current collaboration between EMA and FDA on drug-specific evaluations, collaborative efforts on their development, effective implementation of new pharmacovigilance tools, and how the two organizations address common challenges.

Learning Objective : Distinguish the different approaches taken by EMA and FDA to address common challenges; Identify the complementary approaches to using common tools including the Periodic Benefit Risk Evaluation Reports (PBRER) and the planning of data collection; Recognize how EMA and FDA collaborate on the safety of specific drug reviews and on the development of procedures and guidance.

Speaker(s)

FDA Perspective

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Industry Perspective

Valerie E. Simmons, MD, FFPM

Eli Lilly and Company Ltd, United Kingdom

Senior Medical Fellow, Global Patient Safety

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