ICH Project Workshop on the ICH Q11 Guideline
August 05, 2011
Workshop on the ICH Q11 Guideline was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on August 5, 2011.
This workshop aimed to provide the explanation of ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), and also it would enhance well-understood public consultation.
Approximately 400 participants from pharmaceutical industries attended this workshop and had vigorous Q&A discussion.
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 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 presentation used at the workshop is available in Japanese 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
- August 5, 2011 10:00 a.m.-4:55 p.m.
| Presentation Materials | Speakers |
|---|---|
| Session A: ICH Q11Guideline: Objective and Report of MHLW Study Group in the fiscal year 2010(1,515KB) | Haruhiro Okuda, MHLW(NIHS) |
| Session B: ICH Q11Contents 01_ Manufacturing Process Development(802KB) | |
| Case Study 1 | Kazunori Takagi, MHLW (PMDA) |
| Case Study 2 | Koji Takaki, JPMA |
| 02_Selection of Starting Materials and Source Materials(940KB) | |
| Case Study 4 | Kiyotoshi Matsumura, JPMA |
| Case Study of MHLW Study Group | Haruhiro Okuda, MHLW(NIHS) |
| 03_Control Strategy | Tsuyoshi Ando, MHLW(PMDA/Tokyo University) |
| 04_Process Validation/Evaluation (Case Study 3)(980KB) | |
| 05_Submission of Manufacturing Process Development and Related Information in Common Technical Documents (CTD) Format and Lifecycle Management (Case Study5)(775KB) | Tomonori Nakagawa, JPMA |