ICH Project The 49th ICH Web Conference

Jul 29, 2024

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

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 prohibited.

Date, time and place

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

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Mao Matsumoto (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
02_Q1/Q5C EWG: Revision of Stability Testing Guidelines for Pharmaceuticals Takashi Kameda (NIH)
03_Q2(R2)/Q14 IWG : Revision of "Analytical Method Validation" and "Development of Analytical Methods Ryofumi Samukawa (Pharmaceutical Cooperative Association of Japan)
04_Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceuticals and Biological Products Hiroshi Takeda (NIH)
05_Q5A(R2) IWG: Revision of "Quality of Biopharmaceuticals: Viral Validation Nao Nakamura (Pharmaceutical Cooperative Association)
06_Q6(R1) Informal WG: Revision of "Establishment of Specifications and Test Methods for Pharmaceutical Products Atsuko Orai (NIH)
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 (NIH)
09_M11 EWG: "Electronically Structured and Harmonized Clinical Trial Protocols Hiroshi Sakaguchi (Natl.)
10_M13 EWG: Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms Toru Yamaguchi (Natl.)
11_M15 EWG: General Principles for Model-Informed Drug Development Takuya Nishimura（NISHIMURA） Daisuke Iwata（National Institute for Health Sciences
12_E6(R3) EWG: Revision of "Standards for the Conduct of Clinical Trials of Pharmaceuticals
Hiromi Takizawa (NIMS)
13_E20 EWG: Adaptive Clinical Trials Yuki Watanabe（Chugai Pharmaceutical Co.)
14_E21 EWG: Inclusion of Pregnant and Lactating Women in Clinical Trials Yoko Motoki (Japan Science and Technology Agency)

The End

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