ICH Project The 36th ICH Public Meeting Zendentsu Hall, Tokyo

June 30, 2017

The 36th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on June 30, 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 Montreal from May 27 to June 1, 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
June 30, 2017 10:00 am ~4:35 pm

Program: The 36th ICH Public Meeting (298KB)

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Presentation materials Speakers

Opening remarks

Akira Kawahara, JPMA

01_ICH activities – Summary of the Montreal Meetings- (642KB)

Fumihito Takanashi, MHLW

02_ICH activities – Summary of the Montreal Meetings from JPMA’ view points - (1402KB)

Hironobu Hiyoshi, JPMA

03_E9 (R1) EWG: Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials (224KB)

Yuki Ando, PMDA

04_E17 EWG: General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (513 KB)

Shuji Kamada, PMDA

05_E19 informal WG: Optimisation of Safety Data Collection (505KB)

Kinue Nishioka, PMDA

06_M9 EWG: Biopharmaceutics Classification System-based Biowaivers (BCS) (291KB)

Yutaka Takahashi, JPMA

07_E2B(R3)IWG : Q&As on Electronic Transmission of Individual Case Safety Reports (ICSRs) (793KB)

Manabu Inoue, JPMA

08_M2 EWG: Electronic Standards for the Transfer of Regulatory Information (ESTRI) (876KB)

Mihoko Okada, MHLW (TRI*)

09_ Q11 IWG: Selection and Justification of Starting Materials for the Manufacture of (synthetic) Drug Substances (692KB)

Kazunori Takagi, PMDA

10_Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (853KB)

Yasuhiro Kishioka, PMDA

11_E11(R1) EWG: Clinical Investigation of Medicinal Products in the Pediatric Population (299KB)

Michiyo Sakiyama, PMDA

12_S1 EWG: Revision of the Rodent Carcinogenicity Studies for Human Pharmaceuticals (302KB)

Shigeru Hisada, JPMA

13_S5(R3) EWG: Revision on Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (451KB)

Masao Horimoto, MHLW (CIS*)

14_ S11 EWG: Nonclinical Safety Testing in Support of Development of Paediatric Medicines (267KB)

Kiyoshi Matsumoto, JPMA

15_ M10 EWG: Bioanalytical Method Validation (946KB)

Seiji Tanaka, JPMA

Closing Remarks

Mitsuo Mihara, JPMA

  • *
    TRI: Translational Research Informatics Center
  • *
    CIS: Chiba Institute of Science

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