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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, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
TransCelerate Digital Data Flow (DDF) Overview
Hideo Takaura
TransCelerate BioPharma Inc./ Novartis Pharma K.K., Japan
Head, Technology & Systems Innovation Japan/ Global Drug Development,
David Evans, MS
CDISC, United States
President & CEO
What Can Be Anticipated ?
Noemie Manent, PharmD
European Medicines Agency, Netherlands
TDA-CTT Operations Workstream Lead
Yoshihiro Aoyagi, MS
National Cancer Center Hospital East, Japan
Manager, Department of Medical Information
Hiroshi Sakaguchi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug I