ICHPharmaceutical Regulations in Japan

The 37th ICH Public Meeting
(Zendentsu Hall, Tokyo)

The 37th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on December 15, 2017.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Geneva from November 11 to 16, 2017. 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 240 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 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

Location Date
Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan
December 15, 2017   9:30 am ~3:45 pm

Program: The 37th ICH Public Meeting (PDF 312KB)

Presentation materials Speakers
Opening remarks Akira Kawahara,
JPMA
01_ICH activities – Summary of the Geneva Meetings-  (PDF 708KB) Fumihito Takanashi,
MHLW
02_ICH activities  – Summary of the Geneva Meetings from JPMA’ view points -
(PDF 925KB)
Hironobu Hiyoshi,
JPMA
03_ E17 : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (PDF 1137KB) Yoshiaki Uyama,
PMDA
04_E9(R1) : Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials
(PDF 439KB)
Yuki Ando,
PMDA
05_E19 : Optimisation of Safety Data Collection (PDF 308KB) Kinue Nishioka,
PMDA
06_E8(R1) Revision of General Considerations for Clinical Trials (PDF 1309KB) Mutsuhiro Ikuma,
PMDA
07_E11A Pediatric Extrapolation (PDF 244KB) Shinichi Kijima,
PMDA
08_Q3D(R1) Revised PDEs for the cutaneous and transdermal Route of Administration (PDF 528KB) Akihiko Hirose,
NIHS
09_M9 : Biopharmaceutics Classification System-based Biowaivers (BCS)
(PDF 278KB)
Yukiko Komori,
PMDA
10_S11 : Nonclinical Safety Testing in Support of Development of Pediatric Medicines (PDF 264KB) Kiyoshi Matsumoto,
JPMA
11_M10 : Bioanalytical Method Validation (PDF 858KB) Akiko Ishii,
NIHS
12_E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (ICSRs) (PDF 706KB) Takashi Misu,
PMDA
13_M2 : Electronic Standards for the Transfer of Regulatory Information (ESTRI) (PDF 454KB) Koji Shomoto,
JPMA
14_M8 EWG/IWG: Electronic Common Technical Document (eCTD) (PDF 498KB) Kayoko Ichikawa,
JPMA
Closing Remarks Mitsuo Mihara,
JPMA

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