ICH Project The 37th ICH Public Meeting Zendentsu Hall, Tokyo

December 15, 2017

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 (312KB)

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Presentation materials Speakers

Opening remarks

Akira Kawahara, JPMA

01_ICH activities – Summary of the Geneva Meetings- (708KB)

Fumihito Takanashi, MHLW

02_ICH activities – Summary of the Geneva Meetings from JPMA’ view points -(925KB)

Hironobu Hiyoshi, JPMA

03_ E17 : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (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 (439KB)

Yuki Ando, PMDA

05_E19 : Optimisation of Safety Data Collection (308KB)

Kinue Nishioka, PMDA

06_E8(R1) Revision of General Considerations for Clinical Trials (1309KB)

Mutsuhiro Ikuma, PMDA

07_E11A Pediatric Extrapolation (244KB)

Shinichi Kijima, PMDA

08_Q3D(R1) Revised PDEs for the cutaneous and transdermal Route of Administration (528KB)

Akihiko Hirose, NIHS

09_M9 : Biopharmaceutics Classification System-based Biowaivers (BCS) (278KB)

Yukiko Komori, PMDA

10_S11 : Nonclinical Safety Testing in Support of Development of Pediatric Medicines(264KB)

Kiyoshi Matsumoto, JPMA

11_M10 : Bioanalytical Method Validation (858KB)

Akiko Ishii, NIHS

12_E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (ICSRs) (706KB)

Takashi Misu, PMDA

13_M2 : Electronic Standards for the Transfer of Regulatory Information (ESTRI) (454KB)

Koji Shomoto, JPMA

14_M8 EWG/IWG: Electronic Common Technical Document (eCTD) (498KB)

Kayoko Ichikawa, JPMA

Closing Remarks

Mitsuo Mihara, JPMA

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