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Risk Management in the US, EU and Japan: The Challenges of Diversity
Session Chair(s)
Nancy A Dreyer, PhD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
Two regulators and a global safety officer will discuss differences in legislation and the challenges of risk management planning in the US, EU and Japan.
Learning Objective : Describe differences in legislation for risk management between the US, EU and Japan; Recognize the challenges of different legislation, health care systems and medical practices and translate this knowledge into effective risk management planning.
Speaker(s)
Jeffry M Korn
DIA, United States
Exhibits Manager, DIA Americas
FDA Point of View
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
EU Point of View
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Consultant, United Kingdom
Strategy
Risk Management in Japan
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
Senior Vice President
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