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S29 : Accelerating ICH M11 Implementation: International Collaboration Across Stakeholders for Innovation with the Digital Protocol
Session Chair(s)
Satoru Tsuchiya, MSC
VP, Global Data Design Office , Sumitomo Pharma Co., Ltd. , Japan
Speaker(s)
Hiroshi Sakaguchi
Deputy Review Director, Office of New Drug I , Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Azusa Oda
PROGRAMSTRATEGY & PLANNING DEVELOPMENT / GCO DEVELOPMENT, TransCelerate (Novartis Pharma K.K.), Japan
Hidemi Hasegawa
Global Biostatistics & Data Sciences, CDISC (Nippon Boehringer Ingelheim CO.,Ltd.), Japan
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management, Pfizer R&D Japan G.K., Japan
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