ICH Project ICH M7 (Mutagenic Impurities) Guideline information session
Oct 01, 2014
ICH M7 "Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk" has now been harmonized by the EU, Japan and the US. The meeting was attended not only by members of the Pharmaceutical Manufacturers Association of Japan (PMAJ) but also by representatives from a wide range of companies, etc., and a lively question-and-answer session was held.
We hope that this briefing session will promote understanding of the guideline, disseminate its contents, and help promote innovative new drug development. Work is also in progress for the issuance of the domestic notification, which is expected to be issued soon.
The program, timetable, and presentation materials for this symposium are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
|
Monday, September 29, 2014, 13:30-16:00 |
Japan Pharmaceutical Manufacturers Association |
Information and Program
Lecture Materials
| Presentation | Speaker |
|---|---|
|
00_Opening Remarks |
Hironobu Saito |
|
Issei Komatsu |
|
|
Toshju Hiiragi |
|
|
Junichi Fukuchi |
|
|
04_ Expectations from the industry and recognition of issues (217KB) |
Tsuneo Hashizume |
The End