ICH Project The 47th ICH Public meeting Webinar
July 19, 2023
The 47th ICH public meeting was held in Japan on July 18, 2023.
This Webinar aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Vancouver on June 9 to 14, 2023. At the beginning, we had presentations about the present situation of ICH then move to the topic on the status of various ICH Guidelines.
The Webinar is jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers’ Associations of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, Kansai Pharmaceutical Industries Association and Japan Pharmaceutical Association.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
- Presentation Material
- Only available in Japanese
Date and Format
| Date | Format |
|---|---|
| July 18, 2023 10:00 am ～4:10 pm | Online - Zoom |
Program: The 47th ICH Public Meeting
Side-scrollable
| 13_M15 EWG: General Principles for Model-Informed Drug Development | Daisuke IWATA, PMDA |
| 14_E2D(R1) EWG: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting | Yuka NOZAKA, PMDA |
| 15_E6(R3) EWG: Good Clinical Practice | Izumi OBA, PMDA |
| 16_E11A EWG: Pediatric Extrapolation | Shinichi KIJIMA, PMDA |
| 17_E20 EWG: Adaptive Clinical Trials | Yuki ANDO, PMDA |
| 18_E21 EWG: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials | Yoko MOTOKI, PMDA |
| Closing Remarks | Haruhiko Okuda, PMRJ |