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S01 : Clinical Development Strategy in Light of the New Guidance for Japanese Phase 1 Study before Participating in MRCTs
Session Chair(s)
Jun Oikawa
Kitasato Clinical Research Center, School of Medicine, Kitasato University, Japan
Speaker(s)
Yosuke Kobayashi
Office of New Drug V, Deputy Review Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Naomi Nagai, PHD
Professor, Faculty of Pharmacy, Musashino University, Japan
Yasuhiro Tsuda
Manager/Principal Scientist, Nippon Boehringer Ingelheim Co., Ltd., Japan
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