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

December 21, 2023

The 48th ICH Informal Debriefing Session was held on December 20, 2023 in Prague, Czech Republic (October 28th - November 1st, 2023) 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 48th ICH Debriefing 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 prohibited.

Date, time and place

Date and Time Method of the event
Wednesday, December 20, 2023, 10:00-15:50 Online (Zoom)

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Mao Matsumoto (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
02_M11 EWG : Electronically Structured and Harmonized Clinical Trial Protocols Hiroshi Sakaguchi (Natl.)
03_M12 EWG : Drug Interaction Studies Akihiro Ishiguro（National Institute for Health Sciences)
04_M13 EWG : Bioequivalence Studies for Immediate Release Oral Solid Dosage Forms Toru Yamaguchi (Natl.)
05_M15 EWG: General Principles for Model-Informed Drug Development Takuya Nishimura（NISHIMURA） Daisuke Iwata（National Institute for Health Sciences
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 (NIH)
07_Q1/Q5C EWG: Revision of Guidelines for Stability Studies of Pharmaceutical Products 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 (Japan Pharmaceutical Manufacturers Association)
10_Q5A(R2) EWG: Revision of "Quality of Biopharmaceuticals: Virus Validation Akira SAKURAI (NIH)
11_Q9(R1) IWG: Revision of "Guidelines for Quality Risk Management Tomoaki SAKAMOTO (NIH)
12_E2B(R3) EWG/IWG: Individual Case Safety Report (ICSR) Data Items and Message Specifications
Yukie Yamaguchi (NIH)
13_E6(R3) EWG: Revision of "Standards for Conducting Clinical Studies on Pharmaceuticals Izumi Ohba (NIH)
14_E11A EWG: Extrapolation in Pediatric Drug Development Shinichi KIJIMA (NIH)
15_E20 EWG: Adaptive Clinical Trials Yuki Watanabe（Chugai Pharmaceutical Co.)
16_E21 EWG: Inclusion of Pregnant and Lactating Women in Clinical Trials Yoko Motoki (Japan Science and Technology Agency)

The End

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