ICH Project 30th ICH Immediate Report
Jul 24, 2014
In order to share information on the progress of ICH with companies in charge of drug development and safety assurance, the 30th ICH Immediate Debriefing Session was held on July 10, 2014 at Nagai Memorial Hall in Tokyo, as a forum for presentation and discussion of the outcomes of the ICH Minneapolis Meeting (May 31 - June 5, 2014, Minneapolis, USA). The 30th ICH Debriefing was held on July 10, 2014 at the Nagai Memorial Hall in Tokyo, Japan.
In this session, we reported on the latest developments in ICH in general, and topic experts presented and answered questions on trends in the topics of electronic standards for the communication of regulatory information, efficacy, safety, and quality. Presentations were also made on Future ICH Topics, which began their activities at the ICH Minneapolis meeting.
Approximately 200 participants gathered and many questions were asked, indicating the high level of interest of the participants. The program, timetable, and presentation materials for this meeting are attached below for your direct viewing. Unauthorized copying or reproduction of the attached materials is prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
| Thursday, July 10, 2014, 10:00-16:40 | The Pharmaceutical Society of Japan Nagai Memorial Hall
2-12-15 Shibuya, Shibuya-ku, Tokyo, Japan |
Information and Program
Presentation materials
| Presentations Presentation materials |
Speakers Speakers |
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|---|---|---|
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Hironobu Saito (Daiichi Sankyo) |
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Junko Sato (NIH) |
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Trends in Safety and Complex Areas |
03_M7：Evaluation and Control of DNA Reactive (Mutagenic) Impurities (268KB) |
Junichi Fukuchi (NIH) |
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Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information |
Taku Watanabe (NIH) |
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Future ICH Topics |
Kurajiro Kishi (Pharmaceutical Manufacturers Association of Japan) |
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06_S5（R3）informal WG: Reproductive and Developmental Toxicity Studies (revised) (328KB) |
Michio Fujiwara (Astellas) |
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Kazuhiro Matsui (NIH) |
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Yoshihiro MATSUDA (National Institute for Health Sciences) |
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Trends in Quality Topics |
Chikako SHIKATA (NIHS) |
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Tetsuhito Takarada（Mochida Pharmaceutical Co.) |
The End