ICH Project The 50th ICH Informal Meeting (Web-based)

December 17, 2024

The 50th ICH Informal

Debriefing Session

(

WEB)

will be

held

on December 17, 2024

to present and report the outcome of the ICH Montreal Meeting (November 2-6, 2024, Montreal, Canada) and to share information on the progress of ICH with the public and companies in charge of drug development and ensuring safety and quality of pharmaceutical products. The 50th ICH Immediate Debriefing will be held on the web on December 18, 2024 to present and report the outcome of the ICH Montreal Meeting (Montreal, Canada, November 2-6, 2024).

The meeting will start with a report on ICH developments, including the results of the Montreal meeting, followed by reports from the experts of the working groups on efficacy, multidisciplinary, and quality.
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
Wednesday, December 18, 2024, 13:00-17:05 Online (Zoom)

Information, Program

Information/Program

Horizontal scrolling is available

Presentations Speakers
01-1_Trends in ICH Yasuko Inokuma (Ministry of Health, Labour and Welfare)
01-2_ICH Trend - from JPMA's point of view Masashi Yokota (JPMA)
02_E2D(R1) EWG : Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports Yuka Nosaka (NIHO)
03_E6(R3) EWG : Revision of "Criteria for Conducting Clinical Studies on Pharmaceuticals Hiromi Takizawa (NIHS)
04_E21 EWG : Inclusion of Pregnant and Lactating Women in Clinical Trials Yoko Motoki (NIH)
05_E22 EWG : General Considerations for Patient Preference Trials Shun Tezuka (NIH)
06_M2 EWG : Electronic Standard for Transmission of Regulatory Information on Medicinal Products Koji Numazawa (NIH)
07_M11 EWG : Electronically Structured and Harmonized Clinical Trial Protocol Hiroshi Sakaguchi (NIH)
08_M13 EWG : Bioequivalence for Immediate-Release Solid Oral Dosage Forms Kazuhisa Sekine (JPMA)
09_M4Q(R2) EWG : Revision of "Common Technical Documents - Guidelines for the preparation of quality-related documents Koki Ito (JPMA)
10_Q1/Q5C EWG: Revision of Guidelines for Stability Studies of Pharmaceuticals Tatsuo Koide (NIHS)
11_Q3E EWG : Evaluation and Control of Extractables and Eluates of Pharmaceuticals and Biological Products Hiroshi Takeda (NIHS)
12_Q6(R1) EWG : Revision of "Establishment of Specifications and Test Methods for Pharmaceuticals Takahiro Yamaguchi (JPMA)
13_CGTDG : Cell and Gene Therapies Discussion Group Atsushi Nishikawa (NIH)
　

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