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

Dec. 17, 2024

The 50th ICH Informal Debriefing Session will be held on December 18, 2024, on the web to share information on the progress of ICH with companies in charge of drug development, safety and quality assurance, and the general public. The 50th ICH Debriefing Session will be held on December 18, 2024, on the web.

The meeting will begin 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 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
Wednesday, December 18, 2024, 13:00-17:05 Online (Zoom)

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Yasuko Inokuma (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
02_E2D(R1) EWG : Post-approval safety information: Definitions and criteria for handling and reporting individual case safety reports Yuka Nosaka (NIH)
03_E6(R3) EWG : Revision of "Criteria for Conducting Clinical Studies on Pharmaceuticals Hiromi Takizawa (NIMS)
04_E21 EWG : Inclusion of Pregnant and Lactating Women in Clinical Trials Yoko Motoki (NIH)
05_E22 EWG: General Considerations for Patient Preference Studies Shun Tezuka (NIH)
06_M2 EWG : Electronic Standards for the Transmission of Regulatory Information on Medicinal Products Koji Numazawa (NIH)
07_M11 EWG : Electronically Structured and Harmonized Clinical Trial Protocols Hiroshi Sakaguchi (Natl.)
08_M13 EWG : Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms Kazuhisa Sekine (Pharmaceutical Cooperative Association of Japan)
09_M4Q(R2) EWG : Revision of "Common Technical Documents - Guidelines for Quality Documentation Koki Ito(Pharmaceutical Cooperative Society of Japan)
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 (NIH)
12_Q6(R1) EWG : Revision of "Establishment of Specifications and Test Methods for Pharmaceuticals Takahiro Yamaguchi (Pharmaceutical Co-op)
13_CGTDG : Cell and Gene Therapies Discussion Group Atsushi Nishikawa (NIH)

The End

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