ICH Project Workshop on the ICH M7, Q3D Guidelines (Zendentsu Hall, Tokyo)
April 07, 2015
The workshop on the ICH M7, Q3D Guidelines was held in Japan, which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on April 7, 2015.
This workshop was the opportunity to provide the detailed explanation of ICH Q3D: Guideline for elemental impurities and ICH M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.
Approximately over 350 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion.
This workshop on the M7, Q3D guidelines was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association. All the presentation used at the workshop is available in Japanese as below.
- Working Language
- Japanese
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
- Location
- Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
- Date
- April 7, 2015 10:00 am ~4:40 pm
Presentation materials | Speakers | |
---|---|---|
10:00-10:05 | Opening remarks | Hironobu Saito, JPMA |
ICH Q3D Guideline for Elemental Impurities | ||
10:05-10:15 | Background to Reaching the Step4 (416KB) | Masayuki Mishima, JPMA |
10:15-10:35 | Point of View on Permitted Daily Exposure (654KB) | Akihiko Hirose, NIHS |
10:35-10:55 | Implementation Points to Consider (626KB) | Yuko Uenishi, JPMA |
10:55-11:15 | Point of View on the Scope (157KB) | Toshinori Higashi, PMDA |
11:15-11:30 | Relationship between Q3D and Pharmacopoeia (664KB) | Chikako Yomota, NIHS |
11:30-12:30 | Panel Discussion | ICH Q3D EWG Member |
ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk | ||
13:30-13:45 | Safety (2971KB) | Masamitsu Honma, NIHS |
13:45-14:00 | Quality (314KB) | Yukio Aso, NIHS |
14:00-14:30 | Point to consider of the document of clinical trial notification(206KB) | Junichi Fukuchi, PMDA |
14:30-15:00 | Q&As on the Implementation of ICH M7 Guideline (196KB) | Tsuneo Hashizume, JPMA |
15:20-16:35 | Panel Discussion | ICH M7 EWG Member |
16:35-16:40 | Closing Remarks | Kurajiro Kishi, JPMA |