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LS48 Availability of Structured Data for Clinical Study Protocols after Implementing ICH M11
Session Chair(s)
Hiroshi Matsuzawa, MSc
Clinical Development
Astellas Pharma Inc., Japan
Hajime Osawa
Medical Writing 1G, Biometrics Dept.
Chugai Pharmaceutical Co., Ltd., Japan
Speaker(s)
Manabu Inoue
MSD K.K., Japan
Associate Director, PV IT/Data management, Japan Pharmacovigilance
Niklas Jaenich, PhD, RPh
Boehringer Ingelheim, Germany
Head of Global Labeling Operations and Digitization