ICH Project The 37th ICH Immediate Debriefing Session

December 25, 2017

In order to share information on the progress of ICH with the general public as well as with companies responsible for the development and safety of pharmaceutical products, the 37th ICH Immediate Debriefing Session was held on December 15, 2017, at All Dentsu Hall, Tokyo, Japan.

In this meeting, the experts from the working groups reported on the latest developments in ICH, including the results of the Geneva meeting and new topics, as well as on trends in the topics of efficacy, quality, safety, and electronic standards for the communication of regulatory information on medicinal products, and answered questions. Approximately 240 participants gathered for the event.

Approximately 240 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, timetable, and presentation materials for this debriefing session are attached below as files for your direct viewing.
Unauthorized copying or reproduction of the contents of the attached materials is prohibited.

Date, time, and place of the meeting

Date and time Location
December 15, 2017 (Friday) 9:30-15:45 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Information / Program (312KB)

Presentation Materials

Presentations Speakers

01_2017/11 ICH Geneva Meeting Summary of Results (708KB)

Fumihito Takanashi (Ministry of Health, Labour and Welfare)

02_ICH trends from JPMA's point of view (925KB)

Hironobu Hiyoshi (JPMA)

03_E17 General principles for planning and design of global clinical trials (1137KB)

Yoshiaki Uyama (NIH)

04_E9(R1) Statistical principles for clinical trials (Addendum) (439KB)

Tomonori Ando (NIMS)

05_E19 Optimisation of Safety Data Collection (308KB)

Kinue Nishioka (JAEA)

06_E8(R1): General Considerations for Clinical Studies (R1) (1309KB)

Mutsuhiro Ikuma (JAEA)

07_E11A Pediatric Extrapolation in Pediatric Drug Development (244KB) (in Japanese)

S. Kijima (Natl. Organ.)

08_Q3D(R1) Elemental Impurities (Revision) - PDE for dermal and transdermal administration - (528KB)

Akihiko Hirose (NIHS)

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

Yukiko Komori (NIHS)

10_S11 Non-clinical safety study for pediatric drug development (264KB)

Kiyoshi Matsumoto (JPMA)

11_M10 Bioanalytical Method Validation of Drug Concentration in Biological Samples Bioanalytical Method Validation(858KB)

Akiko ISHII (National Institute of Health Sciences)

12_E2B(R3) EWG/IWG Implementation Guide for Electronic Transmission of Individual Case Safety Report (ICSR) (706KB)

Takashi Noren (NIH)

13_M2 Electronic standards for the transmission of regulatory information on medicinal products (454KB)

Koji SHOMOTO (JPMA)

14_M8 Outcome of eCTD IWG/EWG Geneva meeting (498KB) (in Japanese)

Kayoko ICHIKAWA (JPMA)

 

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