ICH Project Workshop on the ICH M7 Guideline (JPMA, Tokyo)
September 29, 2014
Workshop on the ICH M7 Guideline (JPMA, Tokyo)
Workshop on the ICH M7 Guideline was held in Japan which took place at JPMA office in Tokyo on September 29, 2014.
This workshop aimed to provide the explanation of ICH M7, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk which had reached Step 4 as ICH harmonized tripartite guideline. And now, it enters in implementation period (Step5). The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the information as well as the presentation used at the symposium in Japanese is available as below.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
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- Location
- Japan Pharmaceutical Manufacturers Association (JPMA)
Nihonbashi Life Science Bldg.,2-3-11 Nihonbashi-Honcho,Chuo-ku,Tokyo - Date
- September 29, 2014 1:30 pm ～4:00 pm
- Program Chair
- Masamitsu Honma, MHLW (NIHS)
Tsuneo Hashizume, JPMA
| Presentation materials | Speakers | |
|---|---|---|
| 13:30-13:35 | Welcoming Address | Hironobu Saito, JPMA |
| 13:35-13:45 | Background to reach Step 4 (264KB) | Kazusehi Komatsu, JPMA |
| 13:35-14:00 | Safety Issue (444KB) | Hisami Hiragi, MHLW (PMDA) |
| 14:00-15:00 | Implementation and Quality Issue (259KB) | Junichi Fukuchi, MHLW (PMDA) |
| 14:45-15:00 | Future Prospect and Issues from Industry Position (217KB) | Tsuneo Hashizume, JPMA |
| 15:15-16:00 | Questions and Answers | |