ICH Project ICH Q3D Guidelines and Training Materials
Mar 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 developing training materials including safety assessment and quality control concepts and case studies.
Now that the content of the training material has been agreed upon, a briefing session focusing on the content of the Q3D training material 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, presentation timetable, and presentation materials for this briefing are attached below as files for direct viewing.
The contents of the attached materials may not be copied or reproduced in any form without prior permission.
Date, time and place
| Date and Time | Location |
|---|---|
|
Friday, March 11, 2016, 10:00-16:50 |
All Dentsu Labor Hall (All Dentsu Hall) |
Information and Program
Lecture Materials
| Presentation | Speaker |
|---|---|
|
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 Injectables and Conversion from PDE Values to Concentration Limits (354KB) |
Takumi Ogawa (Q3D IWG Expert, 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) |
The End