ICH Project ICH Q8, Q9, Q10 Guideline Implementation Workshop Follow-up
May 19, 2011 At
the ICH Brussels Meeting in 2003, a new vision for quality, "A New Approach to Drug Quality Based on Risk and Science," was proposed, and since then, guidelines (Q8 (Drug Product Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) were
developed. (Q Trio) have since been developed. Since these Q-trio guidelines differ from the guidelines necessary for actual practice up to Q7 and incorporate new concepts, ICH decided that training on their application was necessary and conducted training in the three regions with content common to Japan, the U.S., and Europe. In Japan, the "ICH Q8, Q9, and Q10 Guideline Implementation Workshops" (hereinafter referred to as "pre-training sessions") were held in Tokyo from October 25 to 27, 2010, and attended by approximately 260 participants from both the business and administrative sides (of which approximately 30% were from the administrative side). In accordance with the purpose of this previous workshop, small-group discussions were held in the breakout sessions by both parties involved on the corporate and administrative sides (examination and investigation).
This year's workshop, with the exception of some sessions (breakout session discussions), was held with as much of the same content as the previous workshop in order to share information with those who were unable to attend the previous workshop due to limited participation, and to provide new information on the results of the previous workshop and the future. More than 330 participants from pharmaceutical and related companies attended the workshop, and a lively question-and-answer session was held in Session D: Panel Discussion.
The materials from the previous workshop, including the original Japanese (English) version of Session B of the workshop, are posted on the following website of the Japan Pharmaceutical Manufacturers Association for your perusal.
ICH Q8, Q9, and Q10 Guideline Implementation Workshop
It is expected that these materials will be appropriate for internal training by companies and the government.
Unauthorized copying or reproduction of the contents of the attached materials for purposes other than those listed above is prohibited.
Date, Time, and Location
| Date and Time | Place |
|---|---|
| April 25, 2011 (Monday) 10:00-17:05 | Tower Hall Funabori Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information, Program
Workshop Materials
You can scroll horizontally.
| Presentations | Speaker (Leader) | |
|---|---|---|
| Session A: Objectives, Results, and Future Directions of the ICH Q8, Q9, and Q10 Guidelines Implementation Workshop | Yukio Hiyama (Eiken), Q-IWG | |
| Session B: Q8, Q9, Q10 Guidelines in Product Life Cycle | Kazuhiro OKOCHI (Takeda), Q-IWG | |
| Yoshihiro Matsuda (NIH), Q-IWG | ||
| 4 Consideration on actual production and pharmaceutical quality system (818KB) | Shigeki Tamura (Astellas Pharma Inc.), Q-IWG | |
| Masatoshi Morisue (NIH), Q-IWG | ||
| Session C: ICH Q8, Q9, Q10 Guidelines Operational Practices Workshop: Outline and Results of Subcommittee Discussions | Eiji Ishikawa (Dainippon Sumitomo Pharma), Q-IWG | |
| Kimiya Okazaki (Pfizer) | ||
| Kenji Hamaura (Daiichi Sankyo) | ||
| Tomonori Nakagawa (Otsuka Pharmaceutical) | ||
| Kazunori Takagi (NIHS) |