ICH Japan Symposium 2018
(The 38th ICH Public Meeting)
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 | Place |
| July 18, 2018 10:00 am ～ 3:35 pm |
Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
|
| Presentation Materials | Speakers | |
| Opening remarks | Akira Kawahara, JPMA |
|
| Movement of ICH | 01_ICH activities - Summary of the Kobe Meetings - (PDF 1435KB) |
Nobumasa Nakashima, MHLW |
| 02_ICH activities - Summary of the Kobe Meetings from JPMA’ viewpoints - (PDF 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 (PDF 915KB) |
Kazushige Maki, PMDA |
| 04_S11 EWG Nonclinical Safety Testing in support of Development of Pediatric Medicines (PDF 351KB) |
Takuya Nishimura, PMDA |
|
| 05_M10 EWG Bioanalytical Method Validation (PDF 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) (PDF 428KB) |
Takashi Misu, JPMA |
| 07_M2 EWG Electronic Standards for the Transfer of Regulatory Information (ESTRI) (PDF 565KB) |
Mihoko Okada, MHLW(*IDIAL) |
|
| 08_M8 IWG / EWG IWG/EWG eCTD (PDF 252KB) |
Ryo Saito, PMDA |
|
| Efficacy Topics Session Chair: Seiki Kanazawa, JPMA |
09_ E8(R1)EWG Revision on General Considerations for Clinical Trials (PDF 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 (PDF 395KB) |
Yuki Ando, PMDA |
|
| 11_E11A EWG Pediatric Extrapolation (PDF 257KB) |
Shinichi Kijima, PMDA |
|
| 12_E19 EWG Optimisation of Safety Data Collection (PDF 332KB) |
Kinue Nishioka, PMDA |
|
| 13_M9 EWG Biopharmaceutics Classification System-based Biowaivers (PDF 326KB) |
Yukiko Komori, PMDA |
|
| Closing Remarks | Mitsuo Mihara, JPMA |
*Institute of Health Data Infrastructure for All
