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Risk Management in the US, EU, and Asia: Where Are We Now?

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
117

Room Number:
6D

Level:
Intermediate

Type:
Session

Title:
Risk Management in the US, EU, and Asia: Where Are We Now?

Chair(s):
Nancy A. Dreyer, PhD, MPH, FISPE
Global Chief of Scientific Affairs, Real-World and Late Phase Research
Quintiles Realworld & Late Phase Research, United States

Description:
This session will provide an overview of the current status of risk management in the US, EU, and Asia, with particular reference to new legislation and its implementation.

Learning Objective(s):
Describe differences in legislation for risk management between the US, EU, and Asia; Recognize challenges of different legislation, health care systems, and medical practice; Implement effective global risk management planning.

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

EU Perspective
Peter Richard Arlett, MRCP
Head of Pharmacovigilance Department
European Medicines Agency, European Union, United Kingdom

Japan Risk Management Plans (RMP): Experience in Its First Year
Stewart Geary, MD
Senior Vice President, Chief Medical Officer
Eisai Co., Ltd., Japan