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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
Eisai Co., Ltd., Japan
MD, Global Safety Officer
PMDA's perspectives on Risk Management and the future for ICH E2C
Shinobu Uzu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director
FDA Perspective on ICH E2 Series
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Risk Management Planning,Canadian Approach
Rania Mouchantaf, PHD
Health Canada, Canada
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
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
Merck Healthcare KGaA, Germany
Senior Director, Head Europe Global Regulatory & Scientific Policy
Expectations and Challenges for Label as Driver and Risk Management Plan from Industry and Drug Development Perspective- From Japan Perspective
Hiromichi Shirasawa, MD
MSD K.K., Japan
Vice President and Executive Officer, Head of Japan Development