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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)
Expectations for ICH M11 from Healthcare Professionals
Yoshihiro Aoyagi, MS
National Cancer Center Hospital East, Japan
Manager, Department of Medical Information
Initiatives for Automated Generation of Clinical Trial Documents Originating from Clinical Trial Protocol, and Expectations for ICH M11
Satoshi Umehara
NTT DATA Corporation, Japan
Manager, Digital Welfare Division, Second Public Sector
Expectations for ICH M11 - Sponsor’s Perspectives –
Yuka Ito
MSD K.K., Japan
Medical Writing, Regulatory Affairs, Japan Development
Hideo Takaura
TransCelerate BioPharma Inc./ Novartis Pharma K.K., Japan
Head, Technology & Systems Innovation Japan/ Global Drug Development,
Daisuke Sato
Ministry of Health, Labour and Welfare (MHLW), Japan
Section Chief, Pharmaceutical Evaluation Division,
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER