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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
Biometrics Dept., Chugai Pharmaceutical Co., Ltd., Japan
Speaker(s)
Manabu Inoue
Associate Director, PV IT/Data management, Japan Pharmacovigilance, MSD K.K., Japan
Niklas Jaenich, PhD, RPh
Head of Global Labeling Operations and Digitization, Boehringer Ingelheim, Germany
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