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 |