ICH Project ICH M7 (Mutagenic Impurities) Guideline Workshops
October 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, US, and Japan and the Guideline Workshops were held with the following program. The meeting was attended not only by JPMA member companies but also by representatives from a wide range of companies, etc., and a lively question and answer session was held.
We hope that the Guideline Workshops will promote understanding of the Guideline, disseminate its contents, and help promote the development of innovative new drugs. 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 of the symposium
| Date and time | Location |
|---|---|
| Monday, September 29, 2014, 13:30-16:00 | Japan Pharmaceutical Manufacturers Association |
Information and Program
Information and Program (313KB)
Lecture Materials
| Presentations | Speakers |
|---|---|
| 00_Opening Remarks | Hironobu Saito |
| Kazumasa Komatsu | |
| Toshju Hiiragi | |
| Junichi Fukuchi | |
| 04_ Expectations from the industry and recognition of issues (217KB) | Tsuneo Hashizume |