ICH Project The 40th ICH Instantaneous Reporting Meeting

July 31, 2019

(Tokyo: All Dentsu Hall)

In order to share information on the progress of ICH with the general public as well as with companies in charge of drug development and safety assurance, the 40th ICH Immediate Debriefing Session was held on July 17, 2019 at All Dentsu Hall in Tokyo, Japan, as a forum for presentation and discussion of the outcomes of the ICH Amsterdam Conference (June 1 - 6, 2019, Amsterdam, the Netherlands). The meeting was held on July 17, 2019, at the All Dentsu Hall in Tokyo, Japan.

In this debriefing session, the experts from each working group reported on the latest developments in ICH, including the results of the Amsterdam meeting and new topics, as well as on trends in the topics of quality, efficacy, safety, and electronic standards, followed by a Q&A session.

A record number of approximately 370 participants attended the meeting, indicating the high level of interest among the participants. The program, presentation timetable, and presentation materials for this debriefing session are attached below as files for direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.

Date, time, and place of the meeting

Date and time Location
July 17, 2019 (Wednesday) 10:00-17:50 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Information / Program (501KB)

Presentation Materials

Presentations Speakers

01_ICH Trends (2019/7) 8th Meeting (Amsterdam) Report (1369KB)

Rei Iwase (Ministry of Health, Labour and Welfare)

02_ICH Trends from JPMA's point of view (1351KB)

Hironobu Hiyoshi (JPMA)

03_Q2 (R2)/Q14: Analytical Procedure Development and Analytical Validation-
-Analytical Procedure Development / Analytical Validation Revision- (1339KB)

Keisuke INOUE (JPMA)

04_Q3D(R2): Elemental Impurities: Dermal and Transdermal PDE (461KB)

Masayuki MISHIMA (JPMA)

05_Q12:
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (June 2019 Amsterdam Conference Report) (605KB)

Masaaki Wada (JPMA)

06_Q13: Continuous Manufacturing of Drug Substances and Drug Products (247KB)

Atsushi Aoyama (NIHS)

07_M9:BCS-based Biowaivers
Biopharmaceutics Classification System-based Biowaivers (654KB)

Hideaki Kuribayashi (NIMS)

08_E8(R1): General guidelines for clinical trials (1350KB)

Mutsuhiro Ikuma (NIMS)

09_E9(R1): Statistical principles for clinical trials (Addendum) (283KB)

Tomonori Ando (NIMS)

10_E11A: Pediatric Extrapolation (244KB) (in Japanese)

Shinichi Kijima (NIH)

11_E17: General principles for planning and designing global clinical trials
training material (2305KB)

Yasuto Ohtsubo (NIH)

12_M11: Electronically Structured Harmonised Protocol Template for Clinical Trials
(CeSHarP: Clinical electronically Structured Harmonised Protocol) (1155KB)

Ken Sakushima (NIH)

13_S5(R3): Reproductive and developmental toxicity study of pharmaceuticals (1231KB) (in Japanese)

Kazushige Maki (NIH)

14_S11: Non-clinical safety study for pediatric drug development (386KB)

Takuya Nishimura (JAEA)

15_M7 (R2): Revision of "Guideline for Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce Potential Carcinogenic Risk" (1565KB) (in Japanese)

Yosuke DEMIZU (National Institute of Health Sciences)

16_E14/S7B: Clinical/non-clinical evaluation of QT/QTc interval prolongation and potential proarrhythmic effects of non-antiarrhythmic drugs (371KB)

Satoshi Tsunoda (Comprehensive Organizational Research Institute)

17_E2B(R3): Implementation guide document for electronic transmission of individual case safety reports (ICSR) (368KB)

Takashi Noren (NIH)

18_M2: Electronic Standards for the Transfer of Regulatory Information (ESTRI) (629KB)

Daisuke Sato (NIMS)

 

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