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Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC
Pfizer R&D Japan G.K., Japan
Speaker(s)
The Current Situation from a CCDS Viewpoint
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
A Comparison of the Adverse Reaction Sections of the Japanese PI, the US PI and the EU SmPC
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
MD, Global Safety Officer
Reflecting “Adverse Reactions” to Labeling for New Drugs and Marketed Drugs PMDA’s Point of View
Tsutomu Mawatari
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of Safety ll