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LS48 Availability of Structured Data for Clinical Study Protocols after Implementing ICH M11
Session Chair(s)
Hiroshi Matsuzawa, MSC
Senior Clinical Expert
Nippon Chemiphar Co., Ltd., Japan
Hajime Osawa
Japan Pharmaceutical Manufacturers Association Data Science Expert Committee
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
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