ICH Project ICH Q8, Q9, Q10 Guideline Implementation Workshop
July 15, 2010
The ICH Project of the Pharmaceutical Manufacturers Association of Japan (JPMA) and the Japan Protocol Association (JPCA) held a workshop on the implementation of the so-called Q Trio Guidelines for ICH Q8 (Drug Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) on October 25-27, 2010, at Tower Hall Funabori, Tokyo, Japan, with common content for Japan, USA and Europe. The workshop was held at Tower Hall Funabori, Tokyo, on October 25-27, 2011.
Unlike ordinary lecture meetings, this workshop was planned to have participants from both the corporate and administrative sides (examination and investigation) actively discuss the issues, so that participants could gain practical and hands-on knowledge and make use of it in their own corporate Q Trio activities. Approximately 260 participants from both the corporate and government sides (including approximately 30% from the government side) attended the workshop.
A summary of this workshop is available in the ICH Japan Symposium 2010 Proceedings as "Trends in Quality Topics: Q-IWG Quality Implementation Working Group".
It is expected that this document will be an appropriate resource for internal training by companies and governments.
Unauthorized copying or reproduction of the contents of the attached document for purposes other than those stated above is prohibited.
Date, time, and place of the meeting
| Date and Time | Place |
|---|---|
| October 25, 2010 (Monday) 13:00-18:00
Tuesday, October 26, 2010 09:30-19:10 October 27, 2010 (Wed) 09:30-14:00 | Tower Hall Funabori
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information, Program
Workshop Materials
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| Presentations | Speaker (Leader) | |
|---|---|---|
| Session A: Introduction | 01_Remarks for the Workshop（ 279KB Session A: Introduction ( 248KB ) | Kohei Wada, Chairperson, ICH Project |
| 02_How to link ICH Q8, Q9 and Q10 Guidelines across the product lifecycle? 515KB 02_ICH Q8, Q9, Q10 Guidelines 707KB ) | Yukio HIYAMA (Eiken), Q-IWG | |
| Session B: Q8 / Q9 / Q10 in Product Life Cycle | 03_Product Development: Case Study Overview ( 739KB Session A 881KB ) | Kazuhiro Okochi (Takeda), Q-IWG |
| 04_Regulatory Review (in Japanese) 724KB , (Takeda Pharmaceutical Co., Ltd.) 474KB ) | Yoshihiro Matsuda (NIH), Q-IWG | |
| 05_Discussion on actual production and pharmaceutical quality system ( 820KB , (1,39MB) 1,39MB ) | Tetsuhito Baoda (Mochida Pharmaceutical), Q-IWG | |
| Masatoshi Morisue (General Organization), Q-IWG | ||
| Session C: Discussion | Track: 07_Design Space ( 402KB Session: 07_Design Space ( 383KB ) | Motoaki Mitsugi (General Organization), Q-IWG |
| Yoshihiro Matsuda (NIH), Q-IWG | ||
| Track: 09_Pharmaceutical Quality System ( 623KB Track: 09_Pharmaceutical Quality System (623KB) 615KB ) | Masatoshi Morisue (NIH), Q-IWG | |
| Yukio Hiyama (Eiken), Q-IWG | ||
| Session D: Q-IWG Activity Report | 11_Quality Implementation Working Group (Q-IWG): Current Status and Update ( 467KB , (515KB) 515KB ) | Eiji Ishikawa (Dainippon Sumitomo Pharma), Q-IWG |