ICH Project The 36th ICH Immediate Debriefing Session

July 14, 2017

In order to share information on the progress of ICH with the general public as well as with companies responsible for drug development and safety, the 36th ICH Immediate Debriefing Session was held in Montreal, Canada (May 27 - June 1, 2017) to present and discuss the results of the ICH Montreal Meeting (May 27 - June 1, 2017, Montreal, Canada). Immediate Debriefing Session was held on June 30, 2017, at All Dentsu Hall, 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 on drugs, quality, and safety, followed by a Q&A session.

Approximately 240 participants gathered and asked many questions, demonstrating the high level of interest among the attendees. The program, lecture timetable, and presentation materials for this debriefing session are attached below as files for direct viewing.
Unauthorized copying or reproduction of the contents of the attached materials is prohibited.

Date, time, and place of the meeting

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

Information / Program (298KB)

Presentation Materials

Presentations Speakers

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

Fumihito Takanashi (Ministry of Health, Labour and Welfare)

02_ICH Trends from JPMA's point of view (1402KB)

Hironobu Hiyoshi (Eisai)

03_E9(R1) (224KB)

Tomonori Ando (NIH)

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

Shuji Kamada (NIH)

05_E19 Optimisation of Safety Data Collection (505KB)

Kinue Nishioka (JAEA)

06_M9 Biopharmaceutics Classification System-based Biowaivers based on BCS (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 Standards 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 (Japan Science and Technology Agency)

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

Yasuhiro Kishioka (NIH)

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

Michiyo Sakiyama (NIH)

12_S1(R1) Carcinogenicity study (revised) (302KB) (in Japanese)

Shigeru Hisada (Asuka Pharmaceutical)

13_S5(R3)Reproductive toxicity study of pharmaceuticals (revised) (451KB)

Masao Horimoto (Chiba University of Science)

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

Kiyoshi Matsumoto (Takeda)

15_M10 Bioanalytical Method Validation of Drug Concentration in Biological Samples (946KB) TANAKA, Seiji (Asuka Pharmaceutical)

Seiji Tanaka (Asuka Pharmaceutical)

 

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