ICH Project ICH Japan Symposium 2018 (38th ICH Instantaneous Reporting Session)

Aug 02, 2018

(Tokyo: All Dentsu Hall)

In order to share information on the progress of ICH with the general public as well as with companies in charge of drug development and safety assurance, the ICH Japan Symposium 2018 (the 38th ICH Imminent Report Meeting) will be held as a forum for presentation and discussion of the outcomes of the ICH Kobe Conference (June 1 - 7, 2018, Kobe, Japan) on It was held on July 18, 2018 at All Dentsu Hall, Tokyo, Japan.

In this briefing session, the latest developments of ICH, such as the results of the Kobe meeting and new topics, were first reported on, as well as trends in the topics of safety and electronic standards for the communication of regulatory information on drugs, and reports and Q&A sessions were held by experts from the Working Groups on each topic of efficacy.

Approximately 210 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. 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 attached materials is strictly prohibited.

Date, time and place

Date and Time Location
Wednesday, July 18, 2018, 10:00 - 15:35 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Information / Program (318KB)

Presentation materials

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  Presentation Speaker
ICH Trends 01_ICH Latest Trends (1,435KB) Nobumasa Nakajima (MHLW)
02_ICH Trends from JPMA's Perspective (1,007KB) Hironobu Hiyoshi (Eisai)
Trends in Safety Topics 03_S5(R3): Reproductive and Developmental Toxicity Studies of Pharmaceuticals (915KB) Kazushige Maki (NIH)
04_S11:Non-clinical safety studies for pediatric drug development (351KB) Takuya Nishimura (NIH)
05_M10: Bioanalytical Method Validation of Drug Concentration in Biological Samples Bioanalytical Method Validation (784KB) Takuya Nishimura(NISHIMURA) Daisuke Iwata(National Institute for Health Sciences
Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information 06_E2B(R3)EWG/IWG: Electronic Transmission of Individual Case Safety Reports (428KB) Takashi Noren (NIMS)
07_M2: Electronic Standard for Transmission of Drug Regulatory Information (565KB) Mihoko Okada (National Institute of Biomedical Innovation)
08_ICH M8: eCTD IWG/EWG (252KB) Ryo Saito (NIMS)
Trends in Efficacy Topics 09_E8(R1) (949KB) Mutsuhiro Ikuma (NIMS)
10_E9(R1) (395KB) Yuki Watanabe(Chugai Pharmaceutical Co.)
11_ICH E11A: Pediatric Extrapolation (257KB) Shinichi Kijima (NIMS)
12_E19: Optimisation of Safety Data Collection (332KB) Kinue Nishioka (NIMS)
13_ICH M9: Biopharmaceutics Classification System-based Biowaivers (326KB) Yukiko Komori (NIMS)

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