ICH Project The 44th ICH Informal Debriefing Session (Web-based)

December 20, 2021

The 44th ICH Informal Debriefing Session will be held on December 22, 2021 on the web to present and discuss the outcomes of the ICH Vancouver Meeting (November 9, 2021 and November 15-18, 2021, WEB) to share information on the progress of ICH with the general public and companies in charge of drug development and safety assurance. The 44th ICH Debriefing Session was held on December 22, 2021 on the web.

In this meeting, the experts from the Working Groups reported on the ICH trends in efficacy, safety, multidisciplinary topics, and quality, followed by a Q&A session.
The program and timetable of this meeting are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached contents is strictly prohibited.

Date, time and place

Date and Time Method of the event
Wednesday, December 22, 2021, 13:00-17:20 Online (Zoom)

Information and Program

Information/Program (284KB)

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Presentation Speaker
01_ICH Trends Egyo Tanabe (MHLW)
02_ICH Trends - From the perspective of the Pharmaceutical Manufacturers Association of Japan Masafumi YOKOTA (Pharmaceutical Manufacturers' Association of Japan)
03_E8(R1) EWG: Revision of "General Guidelines for Clinical Trials Mutsuhiro Ikuma (NIMS)
04_E6(R3) EWG: Revision of "Standards for Conducting Clinical Trials of Medicinal Products Kanako Ito (NIH)
05_E11A EWG: Extrapolation in Pediatric Drug Development Shinichi Kijima (NIMS)
06_E14/S7B IWG: Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential of Non-antiarrhythmic Agents Satoshi Tsunoda (NIH)
07_M14(PEpiDG): General principles for the design of pharmacoepidemiological studies utilizing RWD in safety assessment Kazuhiro Kajiyama (NIH)
08_M8: eCTD Ryo Saito (NIMS)
09_M4Q(R2) IWG: Revision of the Common Technical Documents - Guidelines for Quality Documentation Kazunari Takayama (NIH)
10_M7(R2) Maintenance EWG/IWG: Revision of "Evaluation and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce Potential Carcinogenic Risk Junichi Fukuchi (NIH)
11_Q3E EWG: Evaluation and Control of Leachables and Effusions in Pharmaceuticals and Biological Products Hiroshi Takeda (NIH)
12_Q13 EWG: Continuous Production Kosuke Ito (Natl.)

The End

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