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

July 18, 2018

An ICH regional public meeting entitled ICH Japan Symposium 2018 (The 38th ICH public meeting) was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on July 18, 2018.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Kobe from June 1 to 7, 2018. At the beginning, we had presentations about the present situation of ICH then move to the topic on the status of various ICH Guidelines. Approximately over 210 participants from not only pharmaceutical industries but also relevant industries attended this meeting and had vigorous Q&A discussion.

The public meeting was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by Ministry of Health, Labour and Welfare (MHLW), the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.

Working Language
Japanese
Simultaneous English-Japanese Translation
Not Available

Date and Place

Date Place
July 18, 2018
10:00 am ～ 3:35 pm		 Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan

Side-scrollable

  Presentation Materials Speakers
  Opening remarks Akira Kawahara, JPMA
Movement of ICH 01_ICH activities - Summary of the Kobe Meetings - (1435KB) Nobumasa Nakashima, MHLW
02_ICH activities - Summary of the Kobe Meetings from JPMA' viewpoints - (1007KB) Hironobu Hiyoshi, JPMA
Safety Topics
Session Chair:Kazuto Watanabe, JPMA		 03_S5 (R3) EWG Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (915KB) Kazushige Maki, PMDA
04_S11 EWG Nonclinical Safety Testing in support of Development of Pediatric Medicines (351KB) Takuya Nishimura, PMDA
05_M10 EWG Bioanalytical Method Validation (784KB) Daisuke Iwata, PMDA
Topics for the Electronic Exchange of Information
Session Chair:Manabu Inoue, JPMA		 06_E2B(R3)IWG / EWG Electronic Transmission of Individual Case Safety Reports (ICSRs) (428KB) Takashi Misu, JPMA
07_M2 EWG Electronic Standards for the Transfer of Regulatory Information (ESTRI) (565KB) Mihoko Okada, MHLW(*IDIAL)
08_M8 IWG / EWG IWG/EWG eCTD (252KB) Ryo Saito, PMDA
Efficacy Topics
Session Chair:Seiki Kanazawa, JPMA		 09_ E8(R1)EWG Revision on General Considerations for Clinical Trials (949KB) Mutsuhiro Ikuma, PMDA
10_ E9 (R1) EWG Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials (395KB) Yuki Ando, PMDA
11_E11A EWG Pediatric Extrapolation (257KB) Shinichi Kijima, PMDA
12_E19 EWG Optimisation of Safety Data Collection (332KB) Kinue Nishioka, PMDA
13_M9 EWG Biopharmaceutics Classification System-based Biowaivers (326KB) Yukiko Komori, PMDA
  Closing Remarks Mitsuo Mihara, JPMA
  • *
    Institute of Health Data Infrastructure for All

ICH-branded regional meetings

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