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San Diego Convention Center

Jun 15, 2014 8:30 AM - Jun 19, 2014 12:45 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

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

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

Session Chair(s)

Nancy A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, 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

FDA Perspective

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Peter Richard Arlett, MD, FFPM, FRCP

EU Perspective

Peter Richard Arlett, MD, FFPM, FRCP

European Medicines Agency, Netherlands

Head Data Analytics and Methods Task Force

E. Stewart Geary, MD

Japan Risk Management Plans (RMP): Experience in Its First Year

E. Stewart Geary, MD

Eisai Co., Ltd., Japan

Senior Vice President

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