ICH Project ICH Japan Symposium 2016 (The 35th ICH Public Meeting)

December 14, 2016

An ICH regional public meeting entitled ICH Japan Symposium 2016 (The 35th ICH public meeting) was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo in December 14, 2016.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Osaka from November 5 to 10, 2016. 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 170 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
December 14, 2016
10:00 am ~ 3:45 pm
Zendentsu Hall,3-6, Kanda Surugadai, Chiyoda-ku,
Tokyo, Japan

Program: ICH Japan Symposium 2016 (Japanese) (309KB)

Side-scrollable

  Presentation Materials Speakers
  Opening remarks Akira Kawahara, JPMA
Movement of ICH 01_Progress in one year after Renovation & Future challenge (731KB) Nobumasa Nakashima, MHLW
02_Osaka Meeting through the position of JPMA
- mainly strategic discussion/ New Topics (984KB)
Masafumi Yokota, JPMA
Topics for the Electronic Exchange of Information
Session Chair:Manabu Inoue, JPMA
03_E2B(R3)IWG Q&As on Electronic Transmission of Individual Case Safety Reports (ICSRs) (837KB) Ayumi Endo, PMDA
04_M8 IWG/EWG eCTD (552KB) Taku Watanabe, PMDA
Safety Topics
Session Chair:Kazuto Watanabe, JPMA
05_S5 (R3) EWG Revision on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (244KB) Michio Fujiwara, JPMA
06_S11 EWG Nonclinical Safety Testing in support of Development of Pediatric Medicines (321KB) Yuji Takahashi, NIHS
07_M10 EWG Bioanalytical Method Validation (952KB) Akiko Ishii, NIHS
Efficacy Topics
Session Chair:Seiki Kanazawa, JPMA
08_ E9 (R1) EWG Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials (204KB) Yuki Ando, PMDA
09_E17 EWG General principle on planning/designing Multi-Regional Clinical Trials (423KB) Shuji Kamada, PMDA
10_E18 EWG Genomic Sampling Methodologies for Future Use (304KB) Yu Sakamoto, PMDA
Quality Topics
Session Chair:Kazuhiro Okochi, JPMA
11_Q12 EWG Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (516KB) Yasuhiro Kishioka, PMDA
12_M9 EWG Biopharmaceutics Classification System-based Biowaivers (265KB) Naomi Nagai, PMDA
  Closing Remarks Mitsuo Mihara, JPMA
  • *
    NIHS: National Institute of Health Sciences

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