ICH Project The 51st ICH Informal Debriefing Session (Web-based)

June 30, 2025

The 51st ICH Informal Debriefing Session will be held on July 1, 2025 in Madrid, Spain (May 10-14, 2025) to present the outcome of the ICH Madrid Meeting 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 51st ICH Debriefing Session will be held on July 1, 2025 in Madrid, Spain (May 10-14, 2025).

The meeting will start with a report on the ICH developments at the Madrid meeting, followed by reports from the experts of the working groups on efficacy, quality and multidisciplinary issues, and a Q&A session.
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
Tuesday, July 1, 2025, 13:00-16:35 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_E6(R3) EWG : Revision of GCP (Good Clinical Practice) Hiromi Takizawa (NIH)
03_E22 EWG : General Considerations for Patient Preference Studies Shun Tezuka (NIH)
04_Q3E EWG : Guidelines for Extractables and Eluates of Pharmaceuticals Kazuyoshi Komatsu (Pharmaceutical Cooperative Association of Japan)
05_Q6(R1) EWG : Revision of "Establishment of Specifications and Test Methods for Pharmaceuticals Atsuko Orai (NIH)
06_M4Q(R2) EWG : Revision of "Guidelines for the Preparation of CTD-Quality Documentation Keisuke Tanaka (Natl.)
07_M7 Sub-group : Addendum to "Guidelines for the Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk Keiji Hirabayashi (Natl.)
08_M11 EWG : Electronically Structured and Harmonized Clinical Study Protocols Hiroshi Sakaguchi (Natl.)
09_M13 EWG: Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms Hideaki Kuribayashi (NIH)
10_M14 EWG: General Principles for the Planning, Design and Analysis of Pharmacoepidemiological Studies Using Real World Data in the Safety Assessment of Pharmaceuticals Kazuhiro Kajiyama (Japan Science and Technology Agency)
11_M15 : General Principles for Model-Informed Drug Development Daisuke Iwata (Japan Science and Technology Agency)

The End

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