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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
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of New Drug V, Deputy Review Director
Naomi Nagai, PhD
Musashino University, Japan
Professor, Faculty of Pharmacy
Yasuhiro Tsuda
Nippon Boehringer Ingelheim Co., Ltd., Japan
Manager/Principal Scientist
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