ICH Project ICH M7, Q3D Step 4 Guideline Workshops
May 15, 2015
In June 2014, the ICH M7 “Guideline on the Evaluation and Control of DNA-Reactive(Mutagenic) Impurities in Medicinal Products to Reduce Potential Carcinogenic Risk” was adopted as a harmonized guideline among Japan, the U.S., and the EU in June 2014, and ICH Q3D “Guideline on Elemental Impurities in Medicinal Products” was adopted in December 2014. Accordingly, we held a joint Guideline Workshop on both guidelines according to the schedule below.
More than 350 industry representatives attended this briefing session, and the panel discussion featured a lively question-and-answer session, demonstrating the high level of interest among participants.
The program, presentation schedule, and presentation materials for this briefing session are attached below and can be viewed directly.
Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| Tuesday, April 7, 2015, 10:00 a.m.–4:40 p.m. | Zendentsu Labor Hall (Zendentsu Hall) |
Information and Program
Event Notice and Program (307 KB)
Lecture Materials
| Presentations | Speakers | |
|---|---|---|
| Part 1: 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 Higashi (NIH) | ||
| 05_The Relationship Between ICH Q3D and the Pharmacopoeia (664KB) | 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 Asō (National Institute of Health Sciences) | ||
| 09_Explanation of Documentation Required for Clinical Trial Notification (206 KB) | Junichi Fukuchi (NIH) | |
| 10_Outlook, Requests, and Issues Raised Regarding the Response to the Notification (196KB) | Tsuneo Hashizume (Japan Pharmaceutical Manufacturers Association, CH Project M7 EWG Topic Leader) | |
| 11_Panel Discussion by EWG Members | In addition to the CH M7 EWG members: |