ICH Project Follow-up Workshop on the Practical Application of ICH Q8, Q9, and Q10 Guidelines
May 19, 2011
At the 2003 ICH Brussels Meeting, a new vision for quality titled “A New Approach to Pharmaceutical Quality Based on Risk and Science” was proposed, and subsequently, the Q8 (Product Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems) guidelines (the “Q Trio”) were developed.Unlike the guidelines up to Q7, which were designed for day-to-day operations, these Q-Trio guidelines incorporate new concepts; therefore, the ICH determined that training on their implementation was necessary and conducted training sessions in the three regions—Japan, the U.S., and Europe—using a common curriculum. In Japan, a workshop titled “ICH Q8,Q9, and Q10 Guidelines Practical Implementation Workshop” (hereinafter referred to as the “Previous Workshop”) was held in Tokyo from October 25 to 27, 2010, attended by approximately 260 participants from both the industry and regulatory sectors (of whom approximately 30% were from the regulatory side).In line with the purpose of that previous workshop, small-group discussions involving representatives from both the industry and regulatory sides (review and inspection) were held during the breakout sessions.
With the exception of a few sessions (breakout group discussions), this training session was designed to cover content as similar as possible to that of the previous session, with the aim of sharing information with those who were unable to attend the previous session due to participant limits, while also providing new information on the outcomes of the previous session and future plans.More than 330 participants from pharmaceutical companies and related organizations attended, and a lively question-and-answer session took place during Session D: Panel Discussion.
Please note that the materials from the previous workshop, including the original English version of Session B (which has been translated into Japanese), are available for viewing on the Japan Pharmaceutical Manufacturers Association’s website at the link below.
Practical Training Workshop on the Implementation of ICH Guidelines Q8, Q9, and Q10
These materials are expected to serve as useful resources for internal training conducted by companies and government agencies.
Unauthorized copying or reproduction of the contents of the attached materials for purposes other than those stated above is prohibited.
Date, Time, and Location
| Date and Time | Location |
|---|---|
| Monday, April 25, 2011, 10:00 a.m. – 5:05 p.m. | Tower Hall Funabori, Main Hall
4-1-1 Funabori, Edogawa-ku, Tokyo |
Information and Program
Workshop Materials
You can scroll horizontally
| Presentations | Presenters (Leaders) | |
|---|---|---|
| Session A: Objectives, Results, and Future Directions of the Practical Training Workshop on the Implementation of ICH Q8, Q9, and Q10 Guidelines | Yukio Hiyama (National Institute of Health Sciences), Q-IWG | |
| Session B: Q8, Q9, and Q10 Guidelines in the Product Life Cycle | Kazuhiro Okochi (Takeda Pharmaceutical), Q-IWG | |
| Yoshihiro Matsuda (NIH), Q-IWG | ||
| 4 Considerations Regarding Actual Production and Pharmaceutical Quality Systems (818 KB) | Shigeki Tamura (Astellas Pharma), Q-IWG | |
| Masatoshi Morisue (NIH), Q-IWG | ||
| Session C: ICH Q8, Q9, and Q10 Guidelines Practical Application Workshop—Overview and Results of Breakout Session Discussions | Eiji Ishikawa (Dainippon Sumitomo Pharma), Q-IWG | |
| Koya Okazaki (Pfizer) | ||
| Kenji Hamaura (Daiichi Sankyo) | ||
| Tomonori Nakagawa (Otsuka Pharmaceutical) | ||
| Kazunori Takagi (NIH) |