ICHPharmaceutical Regulations in Japan

Integrated Implementation Training Workshop for ICH Q8, Q9, Q10

Integrated Implementation Training Workshop for ICH Q8, Q9, Q10 was held in Japan at the Tower Hall Funabori, Edogawa-ku in Tokyo from October 25-27, 2011.

This training workshop was aimed to provide comprehensive information of ICH Q8 on Pharmaceutical Development; ICH Q9 on Quality Risk Management; and ICH Q10 on Pharmaceutical Quality System. ICH Quality Implementation Working Group provided the same training contents as other ICH regions in Europe and US.

Approximately 260 participants attended this training workshop from both pharmaceutical industries and regulators (30% participants were from regulator side).

The 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 Ministry of Health, Labour and Welfare (MHLW), Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association. All the information as well as the presentation used at the workshop is available as below.

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available
None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location: Tower Hall Funabori, 4-1-1, Funabori, Edogawa-ku, Tokyo, Japan
Date: October 25, 2010 1:00 p.m.-6:00 p.m.
October 26, 2010 9:30 a.m.-7:10 p.m.
October 27, 2010 9:30 a.m.-2:00 p.m.
Program: Integrated Implementation Training Workshop for ICH Q8, Q9, Q10 (PDF 84KB)

  Presentation materials Speakers
  00_Case Study(PDF 930KB)  
Session A:Introduction 01_ICH Q-IWG Integrated Training Programme(PDF 191KB) Kohei Wada, JPMA
02_How ICH Guidelines are Working Together Throughout the Product Lifecycle(PDF 493KB) Yukio Hiyama, MHLW (NIHS)
Session B: How Q8 / Q9 / Q10 work in life cycle approach 03_Product Development: Case Study Overview(PDF 485KB) Kazuhiro Okochi, JPMA
04_Regulatory Assessment(PDF 434KB) Yoshihiro Matsuda MHLW(PMDA)
05_Manufacturing Implementation and the Pharmaceutical Quality System(PDF 630KB) Tetsuhito Takarada, JPMA
06_Inspection(PDF 365KB) Masatoshi Morisue, MHLW(PMDA)
Session C: Breakout 07_Design Space(PDF 231KB) Leader: Motoaki Mitsuki, MHLW(PMDA)
Kazuhiro Okochi, JPMA
08_Control Strategy(PDF 476KB) Leader: Yoshihiro Matsuda, MHLW(PMDA)
Fusashi Ishikawa, JPMA
09_Pharmaceutical Quality System(PDF 272KB) Leader: Masatoshi Morisue, MHLW(PMDA)
Shigeki Tamura, JPMA
10_Quality Risk Management(PDF 565KB) Leader: Yukio Hiyama, MHLW(NIHS)
Tetsuhito Takarada, JPMA
Hideki Sasaki, JPMA
Session D: Presentation of Q-IWG activities 11_Q-IWG:Status and Update(PDF 315KB) Fusashi Ishikawa, JPMA

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