ICH Project 47th ICH Public Meeting (web-based)

July 19, 2023

The 47th ICH Public Meeting was held on July 18, 2023 in Vancouver, Canada (June 9-14, 2023) to present the results of the ICH Vancouver Meeting 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 47th ICH Debriefing Session was held on July 18, 2023 in Vancouver, Canada (June 9-14, 2023).

The meeting started with a report on the ICH developments, including the results of the Vancouver meeting, followed by reports from the experts of the working groups on quality, multidisciplinary and efficacy, and a Q&A session.
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
Tuesday, July 18, 2023, 10:00-16:10 Online (Zoom)

Information/Program

Information/Program

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

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