ICH Project The 47th ICH Informal Meeting (Web-based)

July 19, 2023

The 47th ICH Informal Debriefing Session (WEB) will be held on July 18, 2023 to present and report the outcome of the ICH Vancouver Meeting (June 9-14, 2023, Vancouver, Canada) and to share information on the progress of ICH with the public and companies in charge of drug development and ensuring safety and quality of pharmaceutical products. The 47th ICH Debriefing Session was held on July 18, 2023 in Vancouver, Canada.

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

Horizontal scrolling is available

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 Guidelines for Stability Studies of Pharmaceuticals Takashi Kameda (NIH)
03_Q2(R2)/Q14 EWG: Revision of "Analytical Method Validation" and "Development of Analytical Methods Mari Takatsu (NIMS)
04_Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceuticals and Biological Products Hiroshi Takeda (NIH)
05_Q5A(R2) EWG: Revision of "Quality of Biopharmaceuticals: Viral Validation Yo Sakurai (NIH)
06_Q9(R1) EWG: Revision of "Guidelines for Quality Risk Management Satoru Aoyama (NIH)
07_Q13 IWG: Continuous Production of Active Pharmaceutical Ingredients and Dosage Forms Yoshinori Kubodera (JPMA)
08_M4Q(R2) EWG: Revision of "Common Technical Documents - Guidelines for
Koki Ito (Japan Pharmaceutical Manufacturers Association)
Koki Ito (JPMA)
09_M2 EWG: Electronic Standard for Transmission of Regulatory Information on Medicinal Products Koji Numazawa (NIHS)
10_M11 EWG: Electronically structured and harmonized clinical trial 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: Revision of "Handling of Post-approval Safety Data Yuka Nosaka (NIH)
14_E6(R3) EWG: Revision of "Criteria for Conducting Clinical Studies on Drugs Izumi Ohba (NIH)
15_E11A EWG: Extrapolation in pediatric drug development S. Kijima (NIH)
16_E20 EWG: Adaptive clinical trials Tomonori Ando (NIH)
17_E21 Informal WG: Inclusion of pregnant and nursing women in clinical trials Yoko Motoki (NIMS)
 

Share this page

TOP