ICH Project The 41st ICH Instantaneous Reporting Meeting
December 25, 2019
(Tokyo: All Dentsu Hall)
In order to share information on the progress of ICH with the general public as well as with companies responsible for drug development and safety assurance, the 41st ICH Immediate Debriefing Session was held as a forum for presentation and discussion of the outcomes of the ICH Singapore Meeting (November 16 - November 20, 2019, Singapore) on December 18, at All Dentsu Hall, Tokyo, Japan.
In this briefing session, the experts from each working group reported on the latest developments in ICH, including the results of the Singapore meeting and new topics, as well as on quality, safety, and efficacy, and answered questions.
About 220 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, timetable, and presentation materials for this debriefing session are attached below as files for direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.
Date, time, and place of the meeting
| Date and time | Location |
|---|---|
| Wednesday, December 18, 2019, 10:00-17:10 | All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo |
Information and Program
Presentation Materials
| Presentations | Speakers |
|---|---|
| 01_ICH Developments Report of the 9th Meeting (Singapore) (1630KB) | Rei Iwase (Ministry of Health, Labour and Welfare) |
| Hironobu Hiyoshi (JPMA) | |
| 03_Q12：Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management（871KB | Satomi Yagi (NIHS) |
| Hiroko SHIBATA (NIHS) | |
| 05_Q13: Continuous Manufacturing of Drug Substances and Drug Products | Jun Aoyama (Natl. Inst. Sci.) |
| Yoji SATO (NIHN) | |
| Satoshi Tsunoda (NIH) | |
| Daisuke Iwata (NIMS) | |
| Mizuho Nonaka (NIH) | |
| Kinue Nishioka (JAEA) | |
| S. Kijima (JAEA) | |
| Ken Sakushima (NIH) | |
| Sho Suzuki (NIH) | |
| Aki Kitabayashi (NIH) | |
| Tomonori Ando (NIH) | |
| 16_M12：Drug Interaction Studies Drug Interaction Studies (757KB) (in Japanese) | Akihiro Ishiguro (NIMS) |