ICH Project The 45th ICH Informal Meeting (Web-based)

Jul 07, 2022

The 45th ICH Informal Debriefing Session was held on July 7, 2022, on the web to share information on the progress of ICH with the public and companies in charge of drug development and safety assurance. The 45th ICH Debriefing was held on July 7, 2022 on the web.

In this meeting, the experts from the working groups reported on the ICH trends, including the results of the Athens meeting, and the experts from the efficacy, quality, and safety working groups gave their reports and answered questions.
The program and timetable of the 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
Thursday, July 7, 2022, 13:00-16:50 Online (Zoom)

Information and Program

Information / Program (279KB)

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Presentation Speaker
01_ICH Trends Mao Yanagisawa (MHLW)
02_ICH Trends - From the perspective of the Pharmaceutical Manufacturers Association of Japan Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
03_E6(R3) EWG: Revision of "Standards for the Conduct of Clinical Trials on Medicinal Products Izumi Ohba (NIH)
04_M14: General Principles for the Planning and Design of Pharmacoepidemiological Studies Utilizing RWD for Safety Assessment of Medicinal Products Kazuhiro Kajiyama (Japan Science and Technology Agency)
05_M4Q(R2): Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documentation Koki Ito (Japan Pharmaceutical Manufacturers Association)
06_Q5A(R2): Revision of "Viral Safety Assessment of Biotechnology Medicinal Products Produced Using Human or Animal Cell Lines Nao NAKAMURA (Japan Pharmaceutical Manufacturers Association)
07_Q9(R1): Revision of "Guidelines for Quality Risk Management Tomoaki SAKAMOTO (National Institute of Health Sciences)
08_Q13: Serial Production of Active Pharmaceutical Ingredients and Preparations Yasuhiro MATSUI (Japan Pharmaceutical Manufacturers Association)
09_S1B(R1): Addendum to the Guidelines for Carcinogenicity Testing of Pharmaceuticals Kumiko OGAWA (National Institute of Public Health)
10_M10: Validation of analytical method for drug concentration in biological samples and analysis of actual samples Daisuke Iwata (Japan Science and Technology Agency)

The End

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