ICH Project 39th ICH Instantaneous Report Meeting

Dec 27, 2018

(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 39th ICH Immediate Debriefing Session was held on December 14, 2018, at All Dentsu Hall in Tokyo, Japan, to present and discuss the outcomes of the ICH Charlotte Conference (November 10 - 15, 2018, Charlotte, USA). The meeting was held on December 14, 2018, at All Dentsu Hall in Tokyo, Japan.

In this debriefing session, the experts from each working group reported and answered questions on quality, efficacy, and safety, along with reports on the latest developments in ICH, including the results of the Charlotte meeting and new topics.

About 220 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 direct viewing.
Please note that the attached materials may not be copied or reproduced without prior permission.

Date, time and place

Date and Time Location
Friday, December 14, 2018, 10:00-16:50 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Meeting Information/Program (490KB)

Presentation materials

Presentation Speaker

01_ICH Trends (2018/11) 7th Meeting at After Charlotte (935KB)

Fumihito Takanashi (MHLW)

02_ICH Trends from JPMA's Perspective (1116KB)

Hironobu Hiyoshi (Pharmaceutical Manufacturers Association of Japan)

03_Q2 (R2)/Q14: Analytical Method Development / Analytical Method Validation Revision (623KB)

Yukio Hiyama (NIHS)

04_Q13:Continuous Manufacturing of Drug Substances and Drug Products (454KB)

Atsushi Aoyama (NIH)

05_E14/S7B: Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects (422KB)

Kaoru Shinagawa (Natl.)

06_E8(R1): General guidelines for clinical trials (revised) (802KB)

Mutsuhiro Ikuma (NIMS)

07_E9(R1): Statistical Principles for Clinical Trials (Addendum) (342KB)

Yuki Watanabe(Chugai Pharmaceutical Co.)

08_E11A: Pediatric Extrapolation Extrapolation in Pediatric Drug Development (288KB)

Shinichi Kijima (NIMS)

09_E17: General principles for planning and designing global clinical trials training material (1576KB) (in Japanese)

Yasuto Ohtsubo (NIH)

10_E19: Optimisation of Safety Data Collection (390KB)

Kinue Nishioka (NIMS)

11_M11: CeSHarP (Clinical electronically Structured Harmonized Protocol) (1269KB)

Motoki Mikami (NIH)

12_S1: Rodent carcinogenicity studies of human pharmaceuticals (500KB)

Kumiko OGAWA (NIHS)

13_S5(R3): Reproductive and Developmental Toxicity Studies of Pharmaceuticals (1200KB)

Kazushige Maki (NIH)

14_M7(R2): Revision of "Guidelines for the Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk" (1406KB)

Masamitsu Homma (National Institute of Health Sciences)

15_M10: Validation of analytical method for drug concentration in biological samples Bioanalytical Method Validation (832KB)

Takuya Nishimura(NISHIMURA) Daisuke Iwata(National Institute for Health Sciences

The End

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