ICH Project 48th ICH Public Meeting (Online)

December 21, 2023

To widely share information on ICH developments with representatives from companies responsible for drug development and ensuring safety and quality, as well as the general public, the 48th ICH Rapid Report Meeting was held as a forum to present and report on the outcomes of the ICH Prague Meeting (Prague, Czech Republic,October 28–November 1, 2023), we held the 48th ICH Public Meeting online on December 20, 2023.

At this briefing, we first provided an overview of ICH trends, including a report on the results of the Prague meeting, followed by presentations and Q&A sessions with experts from various working groups on cross-domain issues, quality, and efficacy.
The program and presentation schedule for this meeting are attached in the file below, so you can view them directly.
Please note that unauthorized copying or reproduction of the attached content is prohibited.

Date, Time, and Venue

Date and Time Format
Wednesday, December 20, 2023, 10:00 a.m.–3:50 p.m. Online (Zoom)

Information and Program

Event Information / Program

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Presentations Speakers
01-1_ICH Trends Mao Matsumoto (MHLW)
01-2_ICH Trends—From the Perspective of the JPMA Masafumi Yokota (JPMA)
02_M11 EWG: Clinical electronic Structured Harmonised Protocol Hiroshi Sakaguchi (PMDA)
03_ICH M12: Drug Interaction Studies Akihiro Ishiguro (PMDA)
04_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms Toru Yamaguchi (PMDA)
05_M15 EWG: General Principles for Model-Informed Drug Development Daisuke Iwata (PMDA)
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 (National Institute of Public Health)
08_Q2(R2)/Q14 EWG: Revision of Validation of Analytical Procedures and Q14 Analytical Procedure Development Hiroko Shibata (National Institute of Public Health)
09_Q3E EWG: Guideline for Extractables and Leachables Kazumasa Komatsu (JPMA)
10_Q5A(R2) EWG:Rivision of "Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin" Haru Sakurai (PMDA)
11_Q9(R1): Revision of "Quality Risk Management" Tomoaki Sakamoto (National Institute of Public Health)
12_E2B(R3) EWG/IWG: Data Elements for Transmission of individual Case Safety Reports Yukie Yamaguchi (PMDA)
13_E6(R3)EWG: Revision of the Guideline for Good Clinical Practice Izumi Oba (PMDA)
14_ICH E11A: Pediatric Extrapolation Shinichi Kijima (PMDA)
15_E20 EWG: Adaptive Clinical Trials Yuki Ando (PMDA)
16_E21 EWG: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Yoko Motoki (PMDA)
　

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