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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
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug I
Azusa Oda
TransCelerate (Novartis Pharma K.K.), Japan
PROGRAMSTRATEGY & PLANNING DEVELOPMENT / GCO DEVELOPMENT
Hidemi Hasegawa
CDISC (Nippon Boehringer Ingelheim CO.,Ltd.), Japan
Global Biostatistics & Data Sciences
Mika Ogasawara
Pfizer R&D Japan G.K., Japan
Data Quality Lead, Biometrics and Data Management