ICH Project 52nd ICH Workshops (Web-based)

Dec 16, 2025

The 52nd ICH Informal Debriefing Session will be held on December 17, 2025 on the web to share information on the progress of ICH with companies in charge of drug development, safety and quality assurance as well as the general public. The 52nd ICH Debriefing will be held on December 17, 2025 on the web.

In this session, the experts from the working groups will present the results of the Singapore meeting and answer questions on quality, safety, efficacy, and multidisciplinary 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 17, 2025, 13:00-17:05 Online (Zoom)

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Fumiya Tamura (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
02_Q1 EWG : Stability studies of drug substance and drug product Junji Ohashi (Japan Pharmaceutical Manufacturers Association)
03_Q6(R1) EWG : Revision of "Establishment of Specifications and Test Methods for Pharmaceutical Products Atsuko Orai (NIH)
04_Q9(R1) Training Group: Revision of "Guidelines for Quality Risk Management Tomonori Nakagawa (Japan Pharmaceutical Manufacturers Association)
05_S13 EWG: Non-clinical Safety Studies of Nucleic Acid Drugs Takasumi Shimomoto (NIH)
06_E14/S7B IWG: Questions and Answers on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects Satoshi Tsunoda (NIH)
07_E21 EWG: Inclusion of pregnant and lactating women in clinical trials Yoko Motoki (NIH)
08_E23 EWG: Considerations on the Use of Real World Evidence (RWE) in Regulatory Decision Making Regarding the Efficacy of Medicinal Products Ryota Kimura (NIH)
09_M7 Sub-group : Addendum to "Guidelines for the Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk Kiyohiro Hashimoto (JPMA)
10_M11 EWG : Electronically Structured and Harmonized Clinical Study Protocols Hiroshi Sakaguchi (Natl.)
11_M13 EWG: Bioequivalence of immediate release oral solid dosage forms Hideaki Kuribayashi (NIH)
12_M15 EWG: General Principles for Model-Informed Drug Development Kenya Nakai (Pharmaceutical Cooperative Society of Japan)
13_M18 EWG: Framework for determining the usefulness of comparative efficacy studies in biosimilar development programs
Naohiro Otaki (Natl.)

The End

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