独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
For immediate Release: July 27, 2012 Media Inquiries: Toshiyoshi Tominaga, +81-3-3506-9456 Title: Convenes the second Science Board meeting
The PMDA convenes the second Science Board meeting ~ Enhancing the review system in response to the Medical Innovations ~
While PMDA has been making various efforts to make its review process faster and more efficient by increasing the number of reviewers and revamping its review system, it is increasingly required to evaluate products using advanced science and technologies precisely and to provide sound advice and guidance.
Under this circumstance, PMDA has been creating a system which ensures constant upskilling of its reviewers enabling them to assess the fruits of advanced technologies in close collaboration with academia that conducts cutting-edge scientific researches. As a part of its effort, PMDA established the Science Board as a high-level organ to give scientific advice. The Board consists of external experts who are active in the front lines of dental, pharmaceutical, and engineering fields.
The second Science Board meeting will be held on July 31 (please refer to the Annex 1 for the list of the Science Board Members, Annex 2 for PMDA organization chart, and Annex 3 for List of the Office of Review Innovation Members.)
The second meeting will discuss appointments of the members of the sub-committees dealing with pharmaceuticals, medical devices, biologics, and cellular- and tissue- based products (regenerative medicinal products). The agenda for the future discussion will be also discussed.
Meeting is closed to public, since specific contents of individual approved products may be referred to. However, a briefing session by the Office of Review Innovation, with the chair of the Board, is scheduled after the meeting as below.
Briefing session Place: PMDA 6th Floor, Meeting Room #8-9 Time and Date: Tuesday, July 31, 2012, 2:15 p.m. – 3:00 p.m.
独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
Annex 1 List of the Science Board Members
(in the Japanese alphabetical order) Akinori Akaike Professor, Graduate School of Pharmaceutical Sciences, Nagoya University
Tatsuro Irimura Professor, Graduate School of Pharmaceutical Sciences, the University of Tokyo
Yukihide Iwamoto Professor, Orthopaedic Surgery, Department of Clinical Medicine, Kyushu University
Hideyuki Okano Professor, Department of Physiology, Graduate School of Medicine, Keio University
Chieko Kai Professor, Institute of Medical Science, the University of Tokyo
Hideo Kusuoka Director General, Osaka National Hospital, National Hospital Organization
Hideo Saji Professor, Graduate School of Pharmaceutical Sciences, Kyoto University
Toshiya Sato Professor, Biostatistics, Public Health, Graduate School of Medicine, Kyoto University
Yuichi Sugiyama Invited Senior Scientist, Sugiyama Laboratory, RIKEN Innovation Center, RIKEN
Tatsutoshi Nakahata Deputy Director, Center for iPS Cell Research and Application, Kyoto University
独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
Masahiro Hayashi Director, Department of Pharmacy, Toranomon Hospital
Akira Matsuda Professor, Faculty of Pharmaceutical Sciences, Hokkaido University
Yoichiro Matsumoto Professor, Graduate School of Engineering, the University of Tokyo
Masaki Mori Professor, Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Nobuhiro Yamada President, University of Tsukuba
Kazuhiko Yamamoto Professor, Graduate School of Medicine, the University of Tokyo
Teruko Yamamoto Professor, Graduate School of Dentistry, Tohoku University
Associate Associate Director Director General Office of Organization Chart of PMDA as of July 2012 Annex 2 Review Director General Director Associate Innovation Office of Regulatory Science Science Board Science Executive Director Director General Office of Review Administration Associate Deputy Deputy Associate Office of Review Management
Secretariat Secretariat Exectuive Director Director Office of Standards and GLs Development Director (Center Director Office of International Programs For Product Evaluation) Associate International Liaison Officers Center Director Office of New Drug Ⅰ-Ⅴ Executive Special Director Associate Assistant Office of Biologics Ⅰ,Ⅱ Executive Director Office of OTC/Generic Drugs Center Director Center Director
Chief - Tissue for Medical Devices Medical for Associate Office of Medical Devices Ⅰ-Ⅲ for cellular and cellular for Deputy Deputy Executive Deputy Center Director Office of Conformity Audit based Products based
Principal Senior Scientists, Senior Scientists
Auditor Senior Information Technology Promotion Group Executive Director Office of Safety Ⅰ, Ⅱ Chief Safety Officer Auditor Office of GMP/QMS Inspection
Chief Actuary Executive Director Chief Relief Officer Office of Relief Funds Office of General Affairs Audit Office Chief Management Office of Financial Management Officer Office of Planning and Coordination
独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
Annex 3
List of the Office of Review Innovation Members
Director General Dr. Hideo Utsumi, Executive Director, PMDA
Associate Director General Dr. Takao Yamori, Director of Center for Product Evaluation, PMDA
Deputy Associate Director General Dr. Akihiro Umezawa, Deputy Center Director (for Cellular and Tissue-based Products), PMDA
Deputy Associate Director General Dr. Ichiro Sakuma, Deputy Center Director (for Medical Devices), PMDA
Secretariat Director Dr. Soichiro Isobe, Office Director, Office of Review Management, PMDA
Deputy Secretariat Director Mr. Masakatsu Imoto, Review Director, Office of Medical Devices III, PMDA
独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
（Reference）
Pharmaceuticals and Medical Devices Agency 〒100-0013 Shin-Kasumigaseki Bldg., 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo TEL： 03-3506-9407（Office of Review Innovation） FAX： 03-3506-9461
＜Place＞ Briefing Session: 6th floor conference Room#8&9 14:15～15:00
【 】 Kasumigaseki Station Map (Chiyoda L・Marunouchi L・Hibiya L） Ext #A13, 8 minutes’ walk
Kokkai-gijido-mae Station （Chiyoda L・Marunouchi L） Exit #3, 5 minutes’ walk
Tameike-sanno Station （Ginza L・ Nanboku L） Exit #8, 7 minutes’ walk
Toranomon Station （Ginza L） Exit #6, 5 minutes’ walk
： URL ttp://www.pmda.go.jp/
独立行政法人
医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency Press Release
【Shin-Kasumigaseki Building 6th Floor】
RECEPTION Conference rooms #6-9
低層エレベータ
Conference rooms #1-5