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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)
Overview and Status Update of Benefit Risk Evaluation & Risk Management Plans
E. Stewart Geary, MD
MD, Global Safety Officer, Eisai Co., Ltd., Japan
PMDA's perspectives on Risk Management and the future for ICH E2C
Shinobu Uzu, PhD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
FDA Perspective on ICH E2 Series
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Risk Management Planning,Canadian Approach
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Expectations and Challenges for Label as Driver and Risk Management Plan from industry and Drug Development Perspective -From US and EU HQ Perspective
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 Japan Perspective
Hiromichi Shirasawa, MD
Vice President and Executive Officer, Head of Japan Development, MSD K.K., Japan
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