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Session-02: Big Picture of ICH Guidelines Revision that Data Manager should Know
Session Chair(s)
Koji Miyata
Manager, Data Management Group, Data Science Development
Astellas Pharma Inc., Japan
Keisuke Utsumi
Head, Development Global Medical, Japan Development Division
GlaxoSmithKline K.K., Japan
Speaker(s)
Two Big Changes GCP Renovation will Bring Us
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Goal of the Revision of ICH E8(R1) "General Considerations for Clinical Studies"
Mutsuhiro Ikuma
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Summary of ICH E9(R1)
Hideki Suganami, PhD
Kowa Company, Ltd., Japan
Global Data Science Center, Head
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