ICH Project The 47th ICH Web Conference

Jul 19, 2023

The 47th ICH Informal Debriefing Session was held on July 18, 2023 in Vancouver, Canada (June 9-14, 2023) to share information on the progress of ICH with the general 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 (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 prohibited.

Date, time and place

Date and Time Method of the event
Tuesday, July 18, 2023, 10:00 a.m. - 4:10 p.m. Online (Zoom)

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Mao Yanagisawa (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
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 "Analytical Method Development Mari Takatsu (NIH)
04_Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceuticals and Biological Products Hiroshi Takeda (NIH)
05_Q5A(R2) EWG: Revision of "Biopharmaceutical Quality: Virus Validation Akira SAKURAI (NIH)
06_Q9(R1) EWG: Revision of "Guidelines for Quality Risk Management Satoru Aoyama (NIH)
07_Q13 IWG: Serial Production of Active Pharmaceutical Ingredients and Dosage Forms M. Takatsu (NIH), M. Kubodera (NIH), K. Numazawa (NIH)
08_M4Q(R2) EWG: Revision of "Common Technical Documents - Guidelines for
EWG: Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents		 Koki Ito(Pharmaceutical Cooperative Society of Japan)
09_M2 EWG: Electronic Standard for the Transmission of Regulatory Information on Medicinal Products Koji Numazawa (NIH)
10_M11 EWG: Electronically Structured and Harmonized Clinical Trial Protocols Hiroshi Sakaguchi (Natl.)
11_M13 EWG: Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms Toru Yamaguchi (Natl.)
12_M15 EWG: General Principles for Model-Informed Drug Development Daisuke Iwata (Japan Science and Technology Agency)
13_E2D(R1) EWG: Revision of "Handling of Post-approval Safety Data Yuka Nosaka (NIH)
14_E6(R3) EWG: Revision of "Standards for Conducting Clinical Trials of Pharmaceutical Products Izumi Ohba (NIH)
15_E11A EWG: Extrapolation in Pediatric Drug Development Shinichi KIJIMA (NIH)
16_E20 EWG: Adaptive Clinical Trials Yuki Watanabe（Chugai Pharmaceutical Co.)
17_E21 Informal WG: Inclusion of pregnant and nursing women in clinical trials Yoko Motoki (Japan Science and Technology Agency)

The End

Back to the Immediate Debriefing Session List

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