ICHPharmaceutical Regulations in Japan

Workshop on the ICH S6 (R1) Guideline

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(PDF 1,635KB) Kazuto Watanabe, JPMA
02_ICH S6(R1) Contents and Specific Considerations(PDF 1,835 KB) Kazushige Maki, MHLW(PMDA)

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