ICH Project The 49th ICH Informal Meeting (Web-based)

July 29, 2024

The 49th ICH Informal Debriefing Session will be held on July 26, 2024 in Fukuoka, Japan to present and report the outcome of the ICH Fukuoka Meeting (June 1 - 5, 2024) and to share information on the progress of ICH with the public and companies in charge of drug development and safety/quality assurance. The meeting was held on July 26, 2024, on the web.

In this meeting, the experts from each working group presented the results of the Fukuoka meeting and answered questions on quality, multidisciplinary, and efficacy issues.
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 Location

Date and time Method of the meeting
Friday, July 26, 2024, 12:30 - 16:50 Online (Zoom)

Information, Program

Information/Program

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Presentations Speakers
01-1_Trends in ICH Mao Matsumoto (Ministry of Health, Labour and Welfare)
01-2_ICH Trends - from JPMA's point of view Masashi Yokota (JPMA)
02_Q1/Q5C EWG: Revision of Guidelines for Stability Studies of Pharmaceuticals Takashi Kameda (NIH)
03_Q2(R2)/Q14 IWG: Revision of "Analytical Method Validation" and "Development of Analytical Methods Ryofumi Samukawa (JPMA)
04_Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceuticals and Biological Products Hiroshi Takeda (NIHS)
05_Q5A(R2) IWG: Revision of "Quality of Biopharmaceuticals: Viral Validation Nao Nakamura (JPMA)
06_Q6(R1) Informal WG: Revision of "Establishment of specifications and test methods for pharmaceutical products Atsuko Orai (NIHS)
07_Q9(R1) IWG: Revision of "Guidelines for Quality Risk Management Satoru Aoyama (NIH)
08_M4Q(R2) EWG: Revision of "Common Technical Documents - Guidelines for
EWG: Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents		 Kazunari Takayama (JAEA)
09_M11 EWG: Electronically structured and harmonized clinical trial protocol Hiroshi Sakaguchi (NIH)
10_M13 EWG : Bioequivalence for Immediate-Release Solid Oral Dosage Forms Toru Yamaguchi (NIH)
11_M15 EWG: General Principles for Model-Informed Drug Development Daisuke Iwata (NIH)
12_E6(R3) EWG: Revision of "Standards for Conduct of Clinical Studies on Drugs
Hiromi Takizawa (NIHO)
13_E20 EWG: Adaptive Clinical Trials Tomonori Ando (NIH)
14_E21 EWG: Inclusion of pregnant and lactating women in clinical trials Yoko Motoki (NIMS)
　

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