ICH Project 47th ICH Public Meeting (Online)

July 19, 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 47th ICH Immediate Report Meeting was held on July 18, 2023, as a forum for presenting and reporting the results of the ICH Vancouver Meeting (Vancouver, Canada,June 9–14, 2023), the 47th ICH Public Meeting was held online on July 18, 2023.

At this briefing, we first provided an update on ICH trends, including the results of the Vancouver meeting. We then held presentations and Q&A sessions with experts from each working group on quality, cross-domain issues, and efficacy.
The program and schedule for this briefing are attached below as a file, which you can view directly.
Please note that unauthorized copying or reproduction of the attached content is prohibited.

Date, Time, and Venue

Date and Time Format
Tuesday, July 18, 2023, 10:00 a.m. – 4:10 p.m. Online (Zoom)

Information and Program

Event Information / Program

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Presentations Speakers
01-1_ICH Trends Mao Yanagisawa (MHLW)
01-2_ICH Trends—From the Perspective of the JPMA Masafumi Yokota (JPMA)
02_Q1/Q5C EWG: Revision of "Stability Testing of Drug Substances and Drug Products" Takashi Kameda (PMDA)
03_Q2(R2)/Q14 EWG: Revision of Validation of Analytical Procedures and Q14 Analytical Procedure Development Mari Takatsu (PMDA)
04_Q3E EWG: Guideline for Extractables and Leachables Hiroshi Takeda (PMDA)
05_Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Haru Sakurai (PMDA)
06_Q9(R1): Revision of "Quality Risk Management" Akira Aoyama (PMDA)
07_Q13 IWG: Continuous Manufacturing of Drug Substances and Drug Products Yoshinori Kubodera (JPMA)
08_M4Q(R2) EWG: Revision of "the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality" Hiroki Ito (JPMA)
09_M2 ERG: Electronic Standards for the Transfer of Regulatory Information Koji Numazawa (PMDA)
10_M11 EWG: Clinical electronic Structured Harmonised Protocol Hiroshi Sakaguchi (PMDA)
11_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms Toru Yamaguchi (PMDA)
12_M15 EWG: General Principles for Model-Informed Drug Development Daisuke Iwata (PMDA)
13_E2D(R1) EWG: Reviion on "Post-approval Safety Data Management" Yuka Nosaka (PMDA)
14_E6(R3)EWG: Revision of the Guideline for Good Clinical Practice Izumi Oba (PMDA)
15_E11A EWG: Pediatric Extrapolation Shinichi Kijima (PMDA)
16_E20 EWG: Adaptive Clinical Trials Yuki Ando (PMDA)
17_E21 Informal WG: Inclusion of Pregnant and Breastfeeding Women in Clinical Trials Yoko Motoki (PMDA)
　

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