Faculty
Jun Yamakami, PHD
Senior Regulatory Expert, Regulatory Affairs Department Regulatory Consulting, A2 Healthcare Corporation, Japan
Dr. Jun Yamakami is a Senior Consultant in the Regulatory Consulting Group, Regulatory Affairs Department at A2 Healthcare Corporation. He joined the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) in 2003 and served as a drug reviewer at the PMDA from 2004 to 2006. From 2008 to 2024, he was responsible for regulatory development activities in the Regulatory Affairs Department at Sanofi K.K. Since 2009, he has been a member of the Program Committee for the DIA Japan Regulatory Affairs Training Course, a program dedicated to fostering professionals from pharmaceutical companies, regulatory authorities, and academia involved in drug development. He has served as Chair of the Program Committee since 2022.
Kazuishi Sekino, MS
Director of MID-NET operation and management, Office of Medical Informatics and , Pharmaceuticals and Medical Devices Agency, Japan
Satoko Utsunomiya
Regulatory Affairs Area, Japan Development, MSD K.K., Japan
Yuko Hata
Associate director, Therapeutic Area Regulatory, Japan Regulatory Affairs, Takeda Pharmaceutical Company, Japan
Akifumi Kamata, PHD
Office of New Drug I, Pharmaceuticals and Medical Devices Agency, Japan
Dr. Akifumi Kamata is a reviewer of Office of Safety II in Pharmaceuticals and Medical Devices Agency (PMDA). In this position, Dr. Kamata is responsible for risk management and pharmacovigilance of vaccines, blood products and biosimilar products. Dr. Kamata has 9 years' experience in PMDA. Dr. Kamata holds a PhD in Pharmaceutical science from Tohoku University.
Miyuki Kaneko
Japan Regulatory Portfolio Lead, Regulatory Affairs, Pfizer R&D Japan G.K., Japan
Japan Regulatory Portfolio Lead, Regulatory Strategy Group 3, Regulatory Strategy & Policy, Regulatory Affairs, Pfizer Japan Inc. Biography: I have worked for Pfizer since 2003. As a Japan Regulatory Lead, I worked on drug development (NDA/ PMDA consultation). I currently work on development drugs in Inflammation, Pain, CNS and Endocrinology as a Japan Regulatory Portfolio Lead. I received my bachelor and master degree in Pharmaceutical Science from Fukuoka University.
Tsuyoshi Kobayashi
Associate Director, Japan Regulatory Affairs, Eisai Co., Ltd., Japan
Yasuhiro Makino
Director, Head of Development Regulatory Affairs 1, RA Dept., Shionogi & Co., Ltd., Japan
Ryutaro Ochiishi
New Drug Regulatory Affairs Department, Daiichi Sankyo, Japan
Maiko Ono
Associate Manager,New Drug Regulatory Affairs, GlaxoSmithKline K.K., Japan
Hiroyuki Takatoku
Strategic Center of Biomedical Advanced Vaccine Research , Japan Agency for Medical Research and Development (AMED), Japan
Toshiki Sugita, PHD
Office of Review Management, Review Management Division, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Toshiki Sugita joined PMDA in 2008. He is in the Review Management Division, Office of Review Management.
Emiko Takezawa, MPHARM, RPH
Regulatory Science, Eliquent Japan, Inc., Japan
Masayoshi Tanaka
, Swedish Orphan Biovitrum Japan (Sobi Japan), Japan
Shunsuke Tominaga, MPHARM, RPH
Head, RA Neauroscience, Gene Therapeutics and Medical Devices, Precision Medicin, Novartis Pharma K.K., Japan
Satomi Yagi
Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hiroki Yokoyama
Head, Global Regulatory Affairs, Japan, Sanofi, Japan
Atsushi Yoshimura
Reviewer, Office of Biologics I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ito Furukawa
Project Leader, Project Development 4, Research and Development, Sanofi-aventis, Japan
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