ICHPharmaceutical Regulations in Japan

Workshop on the ICH Q7 Q&As (Zendentsu Hall, Tokyo)

The workshop on the ICH Q7 Q&As was held in Japan, which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on April 21, 2016.
This workshop was the opportunity to provide the detailed explanation of ICH Q7 Q&As: Q&As on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Approximately over 320 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion.
This workshop was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers’ Associations of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association. All the presentation used at the workshop is available in Japanese as below.

Working Language: Japanese
None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location: Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
April 21, 2016  1:00 pm ~5:35 pm

  Presentation Title Speakers
13:00-13:10 Opening remarks Mitsuo Mihara, JPMA
13:10-13:30 Efforts to ensure the Quality of Active Pharmaceutical Ingredients
- Release of ICH Q7 Q&A Japanese version - (PDF 500KB)
Toshiaki Kudo, MHLW
13:30-13:50 Q7 Q&As History and Related information (PDF 707KB) Masatoshi Morisue, PMDA
13:50-15:10 Q7 Q&As detailed explanation(1) (PDF 1,272KB) Tomonori Nakagawa, JPMA
15:30-16:50 Q7 Q&As detailed explanation(2) (PDF 1,081KB) Tetsuhito Takarada, PMDA
16:50-17:30 Panel Discussion Q7 IWG Members
17:30-17:35 Closing Remarks Mitsuo Mihara, JPMA

Page Top

  • Office of Pharmaceutical Industry Research(OPIR)
  • Global Health
  • Stop AMR
  • APAC