ICH Project 44th ICH Public Meeting (Web-based)

December 20, 2021

The 44th ICH Public Meeting was 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 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 Location

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

Information and Program

Information / Program (284KB)

You can scroll horizontally

Presentations Speakers
01_ICH Trends Egyo Tanabe (Ministry of Health, Labour and Welfare)
02. Trend of ICH - from JPMA's point of view Masashi Yokota (JPMA)
03_E8(R1) EWG: Revision of General Considerations for Clinical Studies Mutsuhiro Ikuma (NIH)
04_E6(R3) EWG: Revision of Guideline for Good Clinical Practice (Principles and Annex 1) Kanako Ito (NIH)
05_E11A EWG: Pediatric Extrapolation Shinichi Kijima (NIH)
06_E14/S7B IWG: Clinical and non-clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of non-antiarrhythmic drugs Satoshi Tsunoda (NIH)
07_M14(PEpiDG): General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines Kazuhiro Kajiyama (NIH)
08_M8: eCTD Ryo Saito (NIH)
09_M4Q(R2) IWG: Revision of The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality Kazunari Takayama (NIH)
10_M7(R2) Maintenance EWG/IWG: Revision of Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Junichi Fukuchi (NIH)
11_Q3E EWG: Evaluation and Control of Leachables and Extractables in Pharmaceuticals and Biological Products Hiroshi Takeda (NIH)
12_Q13: Continuous Manufacturing of Drug Substances and Drug Products Kosuke Ito (NIH)
　

Back to Public Meetings

Share this page

TOP

Site Search