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SESSION 2:UPDATE ON ICH GUIDELINES Track 3 E2 – Global safety Monitoring
Session Chair(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Speaker(s)
E. Stewart Geary, MD
MD, Global Safety Officer, Eisai Co., Ltd., Japan
Overview and Status Update of Benefit Risk Evaluation & Risk Management Plans
Shinobu Uzu, PHD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA's perspectives on Risk Management and the future for ICH E2C
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
FDA Perspective on ICH E2 Series
Rania Mouchantaf, PHD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Risk Management Planning,Canadian Approach
Claudia Hey, DRSC, PHARMD
Senior Director, Head Europe Global Regulatory & Scientific Policy, Merck Healthcare KGaA, Germany
Expectations and Challenges for Label as Driver and Risk Management Plan from industry and Drug Development Perspective -From US and EU HQ Perspective
Hiromichi Shirasawa, MD
Vice President and Executive Officer, Head of Japan Development, MSD K.K., Japan
Expectations and Challenges for Label as Driver and Risk Management Plan from Industry and Drug Development Perspective- From Japan Perspective
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