ICH Project 42nd ICH Instant Report (Web-based)
Dec 01, 2020
The 42nd ICH Informal Meeting was held on the web on December 16, 2020 to share information on the progress of ICH with the general public as well as with companies in charge of drug development and safety assurance.
In previous years, this meeting has been held as an "immediate report" to report on the progress of topics that were intensively discussed face-to-face at the ICH plenary meeting. However, this year, due to the spread of the new coronavirus, two ICH plenary meetings were held virtually, and as a result, intensive face-to-face discussions on the topics could not be held.
The program, timetable, and presentation materials for this meeting are attached below for your direct review.
Unauthorized copying or reproduction of the attached contents is strictly prohibited.
Date, time and place
| Date and Time | Method of the event |
|---|---|
| Wednesday, December 16, 2020, 13:00-16:40 | Online (WebEx) |
Information and Program
Presentation materials
| Presentation | Speaker |
|---|---|
|
Egyo Tanabe (MHLW) |
|
|
Masafumi YOKOTA (Pharmaceutical Manufacturers' Association of Japan) |
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|
Kumiko OGAWA (NIHS) |
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|
Yuto Takishima (NIH) |
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|
Akihiko Hirose（National Institute of Health Sciences) |
|
|
06_Q9（R1）：Quality Risk Management Quality Risk Management (166KB) |
Tomoaki SAKAMOTO (NIHN) |
|
Hiroshi Takeda (NIH) |
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|
Yoji SATO (NIHS) |
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|
Akiko Mase (NIH) |
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Yasuhiro MATSUI (Pharmaceutical Cooperative Association of Japan) |
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Ryosuke Kuribayashi (Japan Pharmaceutical Manufacturers Association) |
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Hiroshi Sakaguchi (Natl.) |
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13_E11A: Pediatric Extrapolation: Extrapolation in Pediatric Drug Development (249KB) |
Shinichi Kijima (NIMS) |
|
14_E20: Adaptive Clinical Trials Adaptive Clinical Trials (157KB) |
Yuki Watanabe（Chugai Pharmaceutical Co.) |
|
Ken Sakushima (NIH) |
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|
16_M12: Drug Interaction Studies Drug Interaction Studies (964KB) |
Shinhiro Hoshino (NIH) |
The End