ICH Project The 48th ICH Informal Meeting (Web-based)

December 21, 2023

The 48th ICH Informal

Debriefing

Session (

WEB)

will be

held

on December 21, 2023

to present and report the outcome of the ICH Prague Meeting (October 28th - November 1st, 2023, Prague, Czech Republic) and to share information on the progress of ICH with the public and companies in charge of drug development and safety and quality assurance. The 48th ICH Debriefing Session was held on December 20, 2023 in Prague, Czech Republic.

In this meeting, the experts from the working groups presented the results of the Prague meeting and answered questions on ICH developments in the areas of multidisciplinary, quality, and efficacy.
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 20, 2023, 10:00-15:50 Online (Zoom)

Information, Program

Information/Program

Horizontal scrolling is available

Presentations Speakers
01-1_Trends in ICH Mao Matsumoto (Ministry of Health, Labour and Welfare)
01-2_ICH Trends - from JPMA's point of view Masashi Yokota (JPMA)
02_M11 EWG : Electronically Structured and Harmonized Clinical Trial Protocol Hiroshi Sakaguchi (NIH)
03_M12 EWG : Drug Interaction Studies Akihiro Ishiguro (NIH)
04_M13 EWG : Bioequivalence for Immediate-Release Solid Oral Dosage Forms Toru Yamaguchi (NIH)
05_M15 EWG: General Principles for Model-Informed Drug Development Daisuke Iwata (NIH)
06_M4Q(R2) EWG: Revision of "Common Technical Documents - Guidelines for Quality Documentation
EWG: Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents		 Kazunari Takayama (Natl.)
07_Q1/Q5C EWG: Revision of Guidelines for Stability Studies of Pharmaceuticals Tatsuo Koide (NIHS)
08_Q2(R2)/Q14 EWG: Revision of "Analytical Method Validation" and "Development of Analytical Methods Hiroko Shibata (NIHS)
09_Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceuticals and Biological Products Kazuyoshi Komatsu (JPMA)
10_Q5A(R2) EWG: Revision of "Quality of Biopharmaceuticals: Viral Validation Yo Sakurai (NIH)
11_Q9(R1) IWG: Revision of "Guidelines for Quality Risk Management Tomoaki Sakamoto (NIHS)
12_E2B(R3) EWG/IWG: Data Items and Message Specifications for Individual Case Safety Report (ICSR)
Yukie Yamaguchi (NIH)
13_E6(R3) EWG: Revision of "Criteria for Conducting Clinical Studies on Drugs Izumi Ohba (NIH)
14_E11A EWG: Extrapolation in pediatric drug development S. Kijima (NIH)
15_E20 EWG: Adaptive clinical trials Tomonori Ando (NIH)
16_E21 EWG: Inclusion of pregnant and nursing women in clinical trials Yoko Motoki (NIH)
　

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