ICH Project 36th ICH Immediate Report

Jul 14, 2017

In order to share information on the progress of ICH with companies in charge of drug development and safety assurance as well as the general public, the 36th ICH Immediate Debriefing Session was held on June 30, 2017, at All Dentsu Hall in Tokyo, Japan, as a forum for presentation and discussion of the outcomes of the ICH Montreal Meeting (May 27 - June 1, 2017, Montreal, Canada). The 36th ICH Immediate Debriefing Session was held on June 30, 2017, at the All Dentsu Hall in Tokyo, Japan.

In this briefing session, the latest developments of ICH, including the results of the Montreal meeting and new topics, were reported by experts on the topics of efficacy, electronic standards for the communication of regulatory information, quality, and safety, followed by a Q&A session.

Approximately 240 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, timetable, and presentation materials for this debriefing session are attached below as files for your direct viewing.
Please note that the attached materials may not be copied or reproduced without prior permission.

Date, time and place

Date and Time Location
Friday, June 30, 2017, 10:00-16:35 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Meeting Information/Program (298KB)

Presentation materials

Presentation Speaker

01_ICH Trends: 2017/06 ICH Montreal Meeting Summary of Results (642KB)

Fumihito TAKANASHI (Ministry of Health, Labour and Welfare)

02_ICH Developments: A JPMA Perspective (1402KB)

Hironobu Hiyoshi (Eisai)

03_E9 (R1) (224KB)

Yuki Watanabe(Chugai Pharmaceutical Co.)

04_E17 General principles for the planning and design of global clinical trials (513KB)

Shuji KAMATA (Natl. Inst. of Health Sci.)

05_E19 Optimisation of Safety Data Collection (505KB)

Kinue Nishioka (NIMS)

06_M9 Biopharmaceutics Classification System-based Biowaivers (291KB)

Yutaka Takahashi (Astellas)

07_E2B(R3)IWG Data items and message specifications for transmitting individual case safety reports (793KB)

Manabu Inoue (MSD)

08_M2 Electronic Standard for Transmission of Drug Regulatory Information (876KB)

Mihoko Okada (Foundation for Biomedical Research and Innovation)

09_Q11 IWG Development and Manufacturing of Active Pharmaceutical Ingredients Q&A (692KB)

Kazunori Takagi (General Pharmaceuticals Organization of Japan)

10_Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (853KB)

Yasuhiro Kishioka (Natl.)

11_E11(R1) Guidance on Clinical Investigation of Medicinal Products in the Pediatric Population (Addendum) (299KB)

Michiyo Sakiyama (NIH)

12_S1(R1)Carcinogenicity Studies (Revised) (302KB)

Shigeru Hisada (Asuka Pharmaceuticals)

13_S5(R3)Reproductive toxicity assays for pharmaceuticals (revised) (451KB)

Masao Horimoto (Chiba University of Science)

14_S11 Non-clinical safety studies using juvenile animals (267KB)

Kiyoshi Matsumoto(Takeda)

15_M10 Bioanalytical Method Validation of Drug Concentration in Biological Samples (946KB)

Kiyoshi Matsumoto (Takeda) Seiji Tanaka (Asuka Pharmaceutical)

The End

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