ICH Project The 42nd ICH Informal Meeting (Web-based)
December 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 and 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 Location
| Date and time | Method of the event |
|---|---|
| Wednesday, December 16, 2020, 13:00-16:40 | Online (WebEx) |
Information, Program
Presentation Materials
| Presentations | Speakers |
|---|---|
| Egyo Tanabe (Ministry of Health, Labour and Welfare) | |
| Masashi Yokota (JPMA) | |
| Kumiko OGAWA (NIHS) | |
| Yuto Takishima (NIH) | |
| Akihiko Hirose (NIHS) | |
| 06_Q9（R1）：Quality Risk Management Quality Risk Management (166KB) (in Japanese) | Tomoaki SAKAMOTO (NIHS) |
| Hiroshi Takeda (Japan Science and Technology Agency) | |
| Yoji SATO (NIHN) | |
| Akiko Mase (NIH) | |
| Yasuhiro MATSUI (JPMA) | |
| Ryosuke Kuribayashi (NIH) | |
| Hiroshi Sakaguchi (NIH) | |
| 13_E11A：Pediatric Extrapolation Extrapolation in Pediatric Drug Development (249KB) (in Japanese) | Shinichi Kijima (NIH) |
| 14_E20: Adaptive Clinical Trials Adaptive Clinical Trials (157KB) | Tomonori Ando (NIMS) |
| Ken Sakushima (NIMS) | |
| 16_M12: Drug Interaction Studies Drug Interaction Studies (964KB) | Shinhiro Hoshino (NIMS) |