ICH Project 48th ICH Public Meeting (web-based)

December 21, 2023

The 48th ICH Public Meeting was held on December 21, 2023, in Prague, Czech Republic, to present the results of the ICH Prague Meeting (October 28 - November 1, 2023) 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 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 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

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Presentations Speakers
01-1_Trends in ICH Mao Matsumoto (MHLW)
01-2_ICH Trends - from JPMA's point of view Masashi Yokota (JPMA)
02_M11 EWG: Clinical electronic Structured Harmonised Protocol Hiroshi Sakaguchi (NIH)
03_ICH M12: 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 "the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality" Kazunari Takayama (NIH)
07_Q1/Q5C EWG: Revision of "Stability Testing of Drug Substances and Drug Products" Tatsuo Koide (NIHS)
08_Q2(R2)/Q14 EWG: Revision of Validation of Analytical Procedures and Q14 Analytical Procedure Development Hiroko Shibata (NIHS)
09_Q3E EWG: Guideline for Extractables and Leachables Kazuyoshi KOMATSU (JPMA)
10_Q5A(R2) EWG:Rivision of "Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin" Yo SAKURAI (NIH)
11_Q9(R1): Revision of "Quality Risk Management" Tomoaki SAKAMOTO (NIHS)
12_E2B(R3) EWG/IWG: Data Elements for Transmission of individual Case Safety Reports Yukie Yamaguchi (NIH)
13_E6(R3)EWG: Revision of the Guideline for Good Clinical Practice Izumi Oba (NIH)
14_ICH E11A: Pediatric Extrapolation Shinichi Kijima (NIH)
15_E20 EWG: Adaptive clinical trials Yuki Ando (NIH)
16_E21 EWG: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Yoko Motoki (NIH)
 

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