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Session 1 - ICH Guideline E2A, E2B(R3) Training
Session Chair(s)
Miyako Shionoiri
Daiichi Sankyo Company, Limited, Japan
Speaker(s)
E2A: Clinical Safety Data Management: Definitions and Standerds for Expedited Reporting
Yuki Marumo
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reveiw Planning Div., Office of Review Management
E2B(R3)-1: Electronic Transmission of Individual Case Safety Reports (ICRs) - 1 (Reguratory Agency’s Viewpoint)
Takashi Misu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Coordinator, Office of International Strategy and Planning
E2B(R3)-2: Electronic Transmission of Individual Case Safety Reports (ICRs) - 2 (Industry’s Viewpoint)
Miyako Shionoiri
Daiichi Sankyo Company, Limited, Japan
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