ICH Project ICH Japan Symposium 2018 (The 38th ICH Immediate Report Meeting)

July 18, 2018

(Tokyo: All Dentsu Hall)

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 assurance, the ICH Japan Symposium 2018 (38th ICH Immediate Report Meeting) was held as a forum for presentation and discussion of the outcomes of the ICH Kobe Meeting (June 1 - June 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 of the meeting

Date and time Location
July 18, 2018 (Wednesday) 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 Speakers
ICH Trends 01_ICH Recent Developments (1,435KB) Nobumasa Nakajima (Ministry of Health, Labour and Welfare)
02_ICH Trends from JPMA's point of view (1,007KB) Hironobu Hiyoshi (Eisai)
Trends in Safety Topics 03_S5(R3): Reproductive and Developmental Toxicity Studies of Drugs (915KB) Kazushige Maki (NIH)
04_S11:Non-clinical safety studies for pediatric drug development (351KB) Takuya Nishimura (JAEA)
05_M10: Bioanalytical Method Validation and Study Sample Analysis Bioanalytical Method Validation (784KB) Daisuke Iwata (NIH)
Trends in Electronic Standards for the Communication of Drug Regulatory Information 06_E2B(R3)EWG/IWG: Electronic transmission of individual case safety reports (428KB) Takashi Noren (Japan Food Safety and Health Organization)
07_M2:Electronic standards for the transmission of drug regulatory information (565KB) Mihoko Okada (National Institute of Biomedical Innovation)
08_ICH M8: eCTD IWG/EWG (252KB) Ryo Saito (Japan Health Sciences Organization)
Trends in Efficacy Topics 09_E8(R1) (949KB) Mutsuhiro Ikuma (NIMS)
10_E9(R1) (395KB) Tomonori Ando (NIMS)
11_ICH E11A: Pediatric Extrapolation (257KB) Shinichi Kijima (NIH)
12_E19: Optimisation of Safety Data Collection (332KB) Kinue Nishioka (JAEA)
13_ICH M9: Biopharmaceutics Classification System-based Biowaivers (326KB) Yukiko Komori (JAEA)
 

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