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Risk Management in the US, EU, and Asia: Where Are We Now?
Session Chair(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Japan Risk Management Plans (RMP): Experience in Its First Year
Learning Objective : 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.
Speaker(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
FDA Perspective
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
EU Perspective
E. Stewart Geary, MD
MD, Global Safety Officer, Eisai Co., Ltd., Japan
Japan Risk Management Plans (RMP): Experience in Its First Year
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