ICH Project ICH Q3D Guidelines and Training Materials Guideline Workshops
March 22, 2016 The
ICH Q3D Guideline for Elemental Impurities in Drugs was issued in Japan on September 30 last year. After the guideline was agreed by the EWG, the IWG has been preparing training materials including safety assessment and quality control concepts and case studies.
Now that the contents of the training materials have been agreed upon, a briefing session focusing on the contents of the Q3D training materials was held to share the latest information with those in charge of pharmaceutical quality and safety.
More than 250 company representatives attended this briefing, and a lively question-and-answer session was held, indicating the high level of interest shown by the participants.
The program, lecture timetable, and presentation materials for this briefing are attached below as files for direct viewing.
Unauthorized copying or reproduction of the contents of the attached materials on this website is strictly prohibited.
Date, time, and place of the meeting
| Date and time | Location |
|---|---|
| Friday, March 11, 2016, 10:00-16:50 | All Dentsu Labor Hall (All Dentsu Hall) |
Information and Program
Information and Program (293KB)
Lecture Materials
| Presentations | Speakers |
|---|---|
| 01_Overview of Q3D Guideline and related information (1193KB) | Chikako Yomota (Topic Leader, Q3D EWG, National Institute of Health Sciences) |
| 02_Risk Assessment of Elemental Impurities/Control of Elemental Impurities (2579KB) | Yuko UENISHI (Deputy Topic Leader, Q3D IWG, ICH Project, Japan Pharmaceutical Manufacturers Association) |
| 03_Large Volume Injectable Drugs and Conversion from PDE Values to Concentration Limits (354KB) | Takumi Ogawa (Expert, Q3D IWG, Pharmaceuticals and Medical Devices Agency) |
| Masayuki MISHIMA (Topic Leader, Q3D IWG, ICH Project, Japan Pharmaceutical Manufacturers Association) | |
| Akihiko Hirose (Topic Leader, Q3D IWG, National Institute of Health Sciences) |