ICH Project ICH M7,Q3D Step 4 Guideline Workshops
May 15, 2015 We
are pleased to announce that ICH M7 "Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk" and ICH Q3D "Guidelines for Elemental Impurities in Pharmaceuticals" were published in June 2014 and December 2014, respectively, harmonized by the three regulatory authorities of Japan, USA and EU. The ICH Q3D "Guidelines for the Evaluation and Management of Elemental Impurities in Pharmaceuticals" and the ICH Q3D "Guidelines for the Evaluation and Management of Elemental Impurities in Pharmaceuticals" were harmonized in Japan, the U.S., and the EU in December 2014.
More than 350 business-related persons participated in this briefing session, and a lively question-and-answer session was held during the panel discussion, indicating the high level of interest of the participants.
The program, lecture timetable, and presentation materials for this briefing session are attached below as files for your direct viewing.
Unauthorized copying or reproduction of the contents of the attached materials on this website is prohibited.
Date, time, and place of the meeting
| Date and time | Location |
|---|---|
| Tuesday, April 7, 2015, 10:00-16:40 | All Dentsu Labor Hall (All Dentsu Hall) |
Information and Program
Information and Program (307KB)
Lecture Materials
| Presentations | Speakers | |
|---|---|---|
| Part I: ICH Q3D | Masayuki Mishima (Topic Leader, ICH Project Q3D EWG, Japan Pharmaceutical Manufacturers Association) | |
| Akihiko Hirose (National Institute of Health Sciences) | ||
| Yuko UENISHI (Deputy Topic Leader, ICH Project Q3D EWG, Japan Pharmaceutical Manufacturers Association) | ||
| Toshinori Azuma (Pharmaceuticals and Medical Devices Agency) | ||
| Chikako SHIKATA (National Institute of Health Sciences) | ||
| 06_Panel Discussion by EWG Members | ICH Q3D EWG members | |
| Part 2: ICH M7 | Masamitsu Homma (National Institute of Health Sciences) | |
| Yukio Aso (National Institute of Health Sciences) | ||
| 09. Explanation of documents at the time of notification of clinical trial (206KB) | Junichi Fukuchi (Pharmaceuticals and Medical Devices Agency) | |
| 10. Prospects, requests and issues raised in response to the notification (196KB) | Tsuneo Hashizume (Topic Leader, CH Project M7 EWG, Japan Pharmaceutical Manufacturers Association) | |
| 11. Panel discussion by EWG members | In addition to CH M7 EWG members |