DIA 2013 49th Annual Meeting
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Risk Management in the US, EU and Japan: The Challenges of Diversity
Track : Track 14: Clinical Safety and Pharmacovigilance
Program Code: 281
Date: Tuesday, June 25, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 153AB
CHAIR :
 Nancy A. Dreyer, PhD,MPH,FISPE (SCHNON), Senior Vice President, Global Chief of Scientific Affairs, Quintiles Outcome, United States
SPEAKER (S):
 Gerald J. Dal Pan, MD (SPKAGY), Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
 Stella C.F. Blackburn, MD,MA,MSc,FFPM,FISPE,FRCP (SCHAGY), EMA Risk Management Development and Scientific Lead, European Medicines Agency, European Union, United Kingdom
 Stewart Geary, MD (SCHNON), Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ, Eisai Co., Ltd., Japan
Description
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. Questions from the audience will be facilitated by a moderator.