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S22 : Beyond ICH M11-How will the Digitalization of Protocol Data Transform Drug Development? ~Future Perspective~
Session Chair(s)
Ken Sakushima, MD, PHD, MPH
Specially Appointed Associate Professor, Research and Development Division, Hokkaido University Hospital, Japan
Satoru Tsuchiya, MSC
VP, Global Data Design Office , Sumitomo Pharma Co., Ltd. , Japan
Speaker(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
Hideo Takaura
Head, Technology & Systems Innovation Japan/ Global Drug Development,, TransCelerate BioPharma Inc./ Novartis Pharma K.K., Japan
TransCelerate Digital Data Flow (DDF) Overview
David Evans, MS
President & CEO , CDISC, United States
Noemie Manent, PHARMD
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
What Can Be Anticipated ?
Yoshihiro Aoyagi, MS
Manager, Department of Medical Information, National Cancer Center Hospital East, Japan
Hiroshi Sakaguchi
Deputy Review Director, Office of New Drug I , Pharmaceuticals and Medical Devices Agency (PMDA), Japan