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Ariake Central Tower Hall and Conference

Nov 05, 2023 9:30 AM - Nov 07, 2023 6:00 PM

Ariake Central Tower 3F, 4F, 3-7-18 Ariake, Koto-ku, Tokyo, 135-0063 Japan

20th DIA Japan Annual Meeting 2023

Rebuilding Drug Development through Society 5.0: The Fusion of Knowledge and Technology that Transcends Time and Space

Back to Agenda

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

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