ICH Project 41st ICH Instant Report Session
December 25, 2019
(Tokyo: All Dentsu Hall)
In order to share information on the progress of ICH with the general public as well as companies in charge of drug development and safety assurance, the 41st ICH Immediate Debriefing Session was held on December 18, 2019 at All Dentsu Hall in Tokyo, as a forum for presentation and discussion of the outcomes of the ICH Singapore Meeting (November 16 - 20, 2019 in Singapore). 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.
Please note that the attached materials may not be copied or reproduced without prior permission.
Date, time and place
| 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
Meeting Information/Program (278KB)
Presentation materials
| Presentation | Speaker |
|---|---|
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01_Trends in ICH - Report on the 9th Meeting (Singapore) (1630KB) |
Rei Iwase (MHLW) |
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Hironobu Hiyoshi (Pharmaceutical Manufacturers Association of Japan) |
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03_Q12：Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management（871KB |
Satomi Yagi (NIH) |
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Hiroko SHIBATA (NIH) |
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05_Q13: Continuous Manufacturing of Drug Substances and Drug Products |
Atsushi Aoyama (NIH) |
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Yoji SATO (NIHS) |
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Satoshi Tsunoda (NIH) |
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Takuya Nishimura（NISHIMURA） Daisuke Iwata（National Institute for Health Sciences |
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Mizuho Nonaka（National Institute for Health Sciences) |
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Kinue Nishioka (NIMS) |
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11_E11A: Pediatric Extrapolation Extrapolation in Pediatric Drug Development (239KB) |
Shinichi Kijima (NIMS) |
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Ken Sakushima (NIH) |
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Sho SUZUKI (Natl. Inst. Sci.) |
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Aki KITABAYASHI (Natl.) |
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Yuki Watanabe（Chugai Pharmaceutical Co.) |
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16_M12：Drug Interaction Studies Drug Interaction Studies (757KB) |
Akihiro Ishiguro（National Institute for Health Sciences) |
The End