ICH Project 40th ICH Instant Reporting Session

Jul 31, 2019

(Tokyo: All Dentsu Hall)

In order to share information on the progress of ICH with the general public as well as 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 prohibited.

Date, time and place

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

Information and Program

Meeting Information/Program (501KB)

Presentation materials

Presentation Speaker

01_Trends in ICH (2019/7) Report on the 8th Meeting (Amsterdam) (1369KB)

Rei Iwase (MHLW)

02_ICH Trends from JPMA's Perspective (1351KB)

Hironobu Hiyoshi (Pharmaceutical Manufacturers Association of Japan)

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

Keisuke INOUE (Japan Pharmaceutical Manufacturers Association for Health Sciences)

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

Masayuki Mishima (Japan Pharmaceutical Manufacturers Association for Health Sciences)

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

Masaaki Wada (Japan Pharmaceutical Manufacturers Association)

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

Atsushi Aoyama (NIH)

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

Hideaki Kuribayashi (NIH)

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

Mutsuhiro Ikuma (NIMS)

09_E9(R1): Statistical Principles for Clinical Trials (Addendum) (283KB)

Yuki Watanabe(Chugai Pharmaceutical Co.)

10_E11A: Pediatric Extrapolation Extrapolation in Pediatric Drug Development (244KB)

Shinichi Kijima (NIMS)

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

Yasuto Ohtsubo (NIH)

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

Ken Sakushima (NIH)

13_S5(R3): Reproductive and Developmental Toxicity Studies of Pharmaceuticals (1231KB)

Kazushige Maki (NIH)

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

Takuya Nishimura (NIH)

15_M7(R2): Revision of "Guidelines for the Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk" (1565KB)

Yosuke Demizu (NIHS)

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

Satoshi Tsunoda (NIH)

17_E2B(R3): Implementation Guide Document for Electronic Transmission of Individual Case Safety Reports (ICSR) (368KB)

Takashi Noren (NIMS)

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

Daisuke Sato (Natl.)

The End

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