ICH Project ICH S6 (R1) Guideline information session ICH S6(R1) Guideline for Non-clinical Safety Assessment of Biopharmaceuticals Briefing Session

August 08, 2011

ICH S6(R1) "Non-clinical Safety Evaluation of Biotechnology-based Medicinal Products" has been harmonized by Japan, the U.S., and the EU. About 100 people from not only pharmaceutical association member companies but also from a wide range of related companies attended the meeting, where a lively Q&A session was held.

The following is a list of the presentation materials used at the briefing.
Unauthorized copying or reproduction of any of the materials is strictly prohibited.

Date, time and place

Date and Time Location

Friday, September 5, 2011, 13:30-16:00

Japan Pharmaceutical Manufacturers Association
2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo

Information and Program

Information of the meeting (151KB)

Briefing Materials

Presentation Speaker

1 ICH S6(R1) Background and Future Expectations (1,635KB)

Japan Pharmaceutical Manufacturers Association
ICH Project S6 (R1) Topic Leader
Kazuto Watanabe

2 ICH S6(R1) contents and points to note (1,835 KB)

Pharmaceuticals and Medical Devices Agency
Kazushige Maki

For inquiries, please contact

ICH Secretariat of the Pharmaceutical Manufacturers' Association of Japan

Phone
03-3241-0326

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