ICH Project ICH Q8, Q9, Q10 Guideline Operational Practices Workshop Follow-up
May 19, 2011
At the ICH Brussels Meeting in 2003, a new vision for quality, "A New Approach to Pharmaceutical Quality Based on Risk and Science," was proposed, and since then, guidelines (Q Trio) for Q8 (Drug Product Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) have been developed. Since then, the Q Trio guidelines have 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, with approximately 260 participants from both the industry and government sides (of which approximately 30% were from the government 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 of 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 (JPMA) for your perusal.
ICH Q8, Q9, Q10 Guideline Implementation Workshop
It is expected that these materials will be appropriate for internal training by companies and governments.
Unauthorized copying or reproduction of the attached materials for purposes other than those stated above is prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
| April 25, 2011 (Monday) 10:00-17:05 | Tower Hall Funabori Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information and Program
Workshop Materials
Horizontal scrolling is available
| Presentation | Speakers (Leaders) | |
|---|---|---|
|
Session A: Objectives, Results, and Future Directions of the ICH Q8, Q9, and Q10 Guidelines Operational Practices Workshop |
Yukio Hiyama (Eiken), Q-IWG |
|
|
Session B: Q8, Q9, and Q10 Guidelines in the Product Lifecycle |
Kazuhiro OKOCHI (Takeda), Q-IWG |
|
|
Yoshihiro Matsuda (NIH), Q-IWG |
||
|
4 Considerations 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 Guideline Implementation Workshop: Overview and Results of the Subcommittee Discussions |
Eiji Ishikawa (Dainippon Sumitomo Pharma), Q-IWG |
|
|
Kimiya Okazaki (Pfizer) |
||
|
Kenji Hamaura (Daiichi Sankyo) |
||
|
Tomonori Nakagawa (Otsuka Pharmaceutical) |
||
|
Kazunori Takagi (General Pharmaceuticals Organization of Japan) |
For inquiries, please contact
ICH Secretariat of the Pharmaceutical Manufacturers' Association of Japan
- Phone
- 03-3241-0326
The End