ICH Project Integrated Implementation Training Workshop for ICH Q8, Q9, Q10

October 25, 2010

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.

Side-scrollable

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

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