ICH Project ICH Japan Symposium 2018 (38th ICH Public Meeting)

July 18, 2018

(Tokyo: Zendentsu Hall)

To widely share information on ICH developments with representatives from companies involved in pharmaceutical development and safety assurance, as well as the general public, the ICH Kobe Meeting(June 1–7, 2018, Kobe, Japan), the ICH Japan Symposium 2018 (38th ICH Public Meeting) was held on July 18, 2018, at the Zendentsu Hall in Tokyo.

At this briefing, participants first heard reports on the latest ICH trends, including the results of the Kobe Conference and new topics, as well as updates on electronic standards for the communication of safety and pharmaceutical regulatory information. This was followed by reports and Q&A sessions with experts from the various working groups on efficacy topics.

Approximately 210 participants attended, and the numerous questions raised demonstrated the high level of interest among attendees. The program, presentation schedule, and presentation materials for this briefing are attached below and can be viewed directly. Please note that unauthorized copying or reproduction of the attached materials is prohibited.

Date, Time, and Venue

Date and Time Location
Wednesday, July 18, 2018, 10:00 a.m. – 3:35 p.m. Zendentsu Labor Hall (Zendentsu Hall)
, 3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Event Notice / Program (318KB)

Presentation Materials

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Presentations Speakers
ICH Trends 01_Latest ICH Developments (1,435 KB) Nobumasa Nakajima (Ministry of Health, Labour and Welfare)
02_ICH Trends from the JPMA Perspective (1,007 KB) Hiroaki Hiyoshi (Eisai)
Trends in Safety-Related Topics 03_S5(R3): Reproductive and Developmental Toxicity Testing of Pharmaceuticals (915 KB) Kazushige Maki (NIH)
04_S11: Nonclinical Safety Studies for the Development of Pediatric Medicines (351 KB) Takuya Nishimura (NIH)
05_M10: Bioanalytical Method Validation and Study Sample Analysis (784KB) Daisuke Iwata (NIH)
Trends in Topics Related to Electronic Standards for the Transmission of Pharmaceutical Regulatory Information 06_E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (428KB) Takashi Misu (NIH)
07_M2: Electronic Standards for the Transmission of Pharmaceutical Regulatory Information (565KB) Michiko Okada (Organization for the Development of Medical Data Utilization Infrastructure)
08_ICH M8: eCTD IWG/EWG (252KB) Ryo Saito (NIH)
Trends in Topics Related to Efficacy 09_E8 (R1) (949 KB) Mutsuhiro Ikuma (NIH)
10_E9 (R1) (395KB) Yuki Ando (NIH)
11_ICH E11A: Pediatric Extrapolation—Extrapolation in the Development of Pediatric Medicines (257KB) Shinichi Kijima (NIH)
12_E19: Optimization of Safety Data Collection (332KB) Kinué Nishioka (NIH)
13_ICH M9: Biowaivers Based on the Biopharmaceutics Classification System (BCS) (326KB) Yukiko Komori (NIH)
 

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