ICH Project The 39th ICH Immediate Debriefing Session

December 27, 2018

(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 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 briefing session, the experts from each working group reported and answered questions on quality, efficacy, and safety, along with the latest developments of ICH, such as the results of the Charlotte meeting and new topics.

Approximately 220 people attended the meeting, and many questions were asked, indicating the high level of interest among the participants. The program, lecture 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
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

Information / Program (490KB)

Presentation Materials

Presentations Speakers

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

Fumihito Takanashi (Ministry of Health, Labour and Welfare)

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

Hironobu Hiyoshi (JPMA)

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

Yukio Hiyama (NIHS)

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

Atsushi Aoyama (Natl. Inst. Sci.)

05_E14/S7B: Clinical and non-clinical evaluation of QT/QTc interval prolongation and potential proarrhythmic effects (422KB)

Kaoru Shinagawa (NIH)

06_E8(R1): General Considerations for Clinical Studies (R1) (802KB)

Mutsuhiro Ikuma (NIMS)

07_E9(R1): Statistical principles for clinical trials (addendum) (342KB)

Tomonori Ando (NIMS)

08_E11A: Pediatric Extrapolation (288KB) (in Japanese)

Shinichi Kijima (NIH)

09_E17: General principles for planning and design of 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) (in Japanese)

Motoki Mikami (NIH)

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

Kumiko OGAWA (NIHS)

13_S5(R3): Reproductive and developmental toxicity study of pharmaceuticals (1200KB)

Kazushige Maki (National Institute for Health Sciences)

14_M7 (R2): Revision of "Guideline for Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce Potential Carcinogenic Risk" (1406KB)

Masamitsu Homma (NIHS)

15_M10: Bioanalytical Method Validation and Study Sample Analysis Bioanalytical Method Validation (832KB)

Daisuke Iwata (NIHS)

 

Share this page

TOP