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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
TransCelerate Digital Data Flow (DDF) Overview
Hideo Takaura
Head, Technology & Systems Innovation Japan/ Global Drug Development,, TransCelerate BioPharma Inc./ Novartis Pharma K.K., Japan
David Evans, MS
President & CEO , CDISC, United States
What Can Be Anticipated ?
Noemie Manent, PharmD
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
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
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