ICH Project Workshop on the ICH S6 (R1) Guideline
September 05, 2011
Workshop on the ICH S6 (R1) Guideline was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on September 5, 2011.
This workshop aimed to provide the explanation of ICH S6 (R1), Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals which had reached Step 4 as ICH harmonized tripartite guideline. Approximately 100 participants from pharmaceutical industries attended this workshop and had vigorous Q&A discussion.
The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the presentation used at this 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
- Japan Pharmaceutical Manufacturers Association (JPMA)
Nihonbashi Life Science Bldg.,2-3-11 Nihonbashi-Honcho,Chuo-ku,Tokyo - Date
- September 5, 2011 1:30 p.m.-4:00 p.m.
| Presentation materials | Speakers |
|---|---|
| 01_ICH S6(R1) Background and Future Perspective(1,635KB) | Kazuto Watanabe, JPMA |
| 02_ICH S6(R1) Contents and Specific Considerations(1,835 KB) | Kazushige Maki, MHLW(PMDA) |