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

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
246

Room Number:
6D

Level:
Intermediate

Type:
Session

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

Chair(s):
Peter Richard Arlett, MRCP
Head of Pharmacovigilance Department
European Medicines Agency, European Union, United Kingdom

Description:
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(s):
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.

Presentation(s) & Speaker(s):
FDA Perspective
Gerald J. Dal Pan, MD
Director, Office of Surveillance and Epidemiology, CDER
FDA, United States

Industry Perspective
Valerie E. Simmons, MD, FFPM
EU QPPV, Executive, Global Patient Safety
Eli Lilly and Company Ltd, United Kingdom