ICH Project ICH M7,Q3D Step 4 Guideline briefing
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 harmonized in June 2014 and December 2014, respectively, by the EU, Japan and USA, The joint briefing session on the two guidelines was held as follows.
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 direct viewing.
Unauthorized copying or reproduction of any of the attached materials is prohibited and will be posted on this website.
Date, time and place
| Date and Time | Location |
|---|---|
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Tuesday, April 7, 2015 10:00-16:40 |
All Dentsu Labor Hall (All Dentsu Hall) |
Information and Program
Lecture Materials
| Presentation | Speaker | |
|---|---|---|
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Part I: ICH Q3D |
Masayuki Mishima (Topic Leader, ICH Project Q3D EWG, Japan Pharmaceutical Manufacturers Association) |
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Akihiko Hirose (National Institute of Health Sciences) |
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Yuko Uenishi (Deputy Topic Leader, ICH Project Q3D EWG, Japan Pharmaceutical Manufacturers Association) |
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Toshinori Azuma (Pharmaceuticals and Medical Devices Agency) |
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Chikako Yomota (National Institute of Health Sciences) |
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06_Panel Discussion by EWG Members |
ICH Q3D EWG Members |
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Part 2: ICH M7 |
Masamitsu Homma (National Institute of Health Sciences) |
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Yukio Aso (National Institute of Health Sciences) |
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09. Explanation about documents at the time of clinical trial notification (206KB) |
Junichi Fukuchi (Pharmaceuticals and Medical Devices Agency) |
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10. Prospects, requests, and issues raised in response to notification (196KB) |
Tsuneo Hashizume, CH Project M7 EWG Topic Leader, Japan Pharmaceutical Manufacturers Association |
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11_Panel discussion by EWG members |
In addition to CH M7 EWG members |
The End