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S26 : Beyond ICH M11-How will Drug Development Change? ~ Issues in Japan
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)
Yoshihiro Aoyagi, MS
Manager, Department of Medical Information, National Cancer Center Hospital East, Japan
Expectations for ICH M11 from Healthcare Professionals
Satoshi Umehara
Manager, Digital Welfare Division, Second Public Sector , NTT DATA Corporation, Japan
Initiatives for Automated Generation of Clinical Trial Documents Originating from Clinical Trial Protocol, and Expectations for ICH M11
Yuka Ito
Clinical Pharmacology Area, Japan Development, MSD K.K., Japan
Expectations for ICH M11 - Sponsor’s Perspectives –
Hideo Takaura
Head, Technology & Systems Innovation Japan/ Global Drug Development,, TransCelerate BioPharma Inc./ Novartis Pharma K.K., Japan
Daisuke Sato, MSC
Section Chief, Pharmaceutical Evaluation Division,, Ministry of Health, Labour and Welfare (MHLW), Japan
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
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