The PMDA convenes the second Science Board meeting

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
Organization Chart of PMDA
Secretariat
Director
Associate
Deputy
Director
Associate
General Director General
Associate
Executive Director
as of July 2012
Annex 2
Office of Regulatory Science
Office of Review Administration
Associate
Exectuive Director
Office of Review Management
Office of Standards and GLs Development
Director (Center
For Product
Evaluation)
Science Board
Special
Assistant
Director General
Office of
Review
Innovation
Executive
Director
Office of International Programs
Associate
Center Director
International Liaison Officers
Office of New Drug Ⅰ-Ⅴ
Associate
Executive Director
Office of Biologics Ⅰ,Ⅱ
Office of OTC/Generic Drugs
Associate
Center Director
Office of Medical Devices Ⅰ-Ⅲ
Office of Conformity Audit
Principal Senior Scientists, Senior Scientists
Information Technology Promotion Group
Chief Safety Officer
Office of Safety Ⅰ, Ⅱ
Office of GMP/QMS Inspection
Executive
Director
Audit Office
for Medical Devices
Auditor
Deputy
Center Director
Senior
Executive
Director
for cellular and
Tissue-based Products
Auditor
Deputy
Center Director
Chief
Executive
Chief Actuary
Chief Relief Officer
Office of Relief Funds
Office of General Affairs
Chief Management
Officer
Office of Financial Management
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
(Chiyoda L・Marunouchi L・Hibiya L）
Ext #A13, 8 minutes’ walk
【Map】
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
【Shin-Kasumigaseki Building 6th Floor】
Conference rooms
#6-9
RECEPTION
低層エレベータ
Conference rooms
#1-5
Press Release