ICH Project The 46th ICH Web Conference

December 23, 2022

The 46th ICH Informal Debriefing Session was held on December 22, 2022 in Inchon, Korea (November 12-16, 2022) to share information on the progress of ICH with companies in charge of drug development and safety assurance as well as the general public. The 46th ICH Debriefing Session was held on December 22, 2022 at the Web site.

In this meeting, the experts from the working groups reported on the ICH trends, including the results of the Inchon Meeting, as well as on efficacy, multidisciplinary, and quality issues.
The program and timetable of the meeting are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached contents is prohibited.

Date, time and place

Date and Time Method of the event
Thursday, December 22, 2022, 13:00-17:00 Online (Zoom)

Information and Program

Information/Program

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Presentation Speaker
01-1_ICH Trends Mao Yanagisawa (MHLW)
01-2_ICH Trends - From a Pharmaceutical Association Perspective Masashi Yokota (Pharmaceutical Manufacturers Association of Japan)
02_E6(R3) EWG : Revision of "Criteria for Conducting Clinical Studies on Pharmaceuticals Izumi Ohba (NIH)
03_E11A EWG :Extrapolation in Pediatric Drug Development Shinichi Kijima (NIMS)
04_M13A EWG : Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms Ryosuke Kuribayashi (Japan Pharmaceutical Manufacturers Association)
05_M15 EWG : General Principles for Model-Informed Drug Development Takuya Nishimura（NISHIMURA） Daisuke Iwata（National Institute for Health Sciences
06_M4Q(R2) EWG : Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents
EWG : Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents		 Kazunari Takayama (NIH)
07_Q1/Q5C EWG : Targeted Revisions of the ICH Stability Guideline Series Junji Ohashi (Pharmaceutical Cooperative Association of Japan)
08_Q3E EWG: Evaluation and Control of Eluates and Effusions of Pharmaceuticals and Biological Preparations Hiroshi Takeda (NIH)
09_Q9(R1) EWG : Revision of "Guidelines for Quality Risk Management Satoru Aoyama (NIH)
10_Q13 EWG : Continuous Production of Active Pharmaceutical Ingredients and Preparations Kosuke Ito (Natl.)

The End

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