ICH Project ICH Q3D Guideline Workshops and Training Materials Briefing
March 22, 2016
The ICH Q3D Guideline on Elemental Impurities in Medicinal Products was issued in Japan on September 30 of last year. Following the agreement on the guideline within the EWG, the IWG has been working on the development of training materials that include safety assessment and quality control concepts as well as case studies.
Now that the content of the training materials has been finalized, we held an information session focused on the Q3D training materials to share the latest information with those responsible for pharmaceutical quality and safety.
Over 250 industry representatives attended this briefing session, and a lively question-and-answer session took place, demonstrating the high level of interest among participants.
The program, presentation schedule, and presentation materials for this briefing session are attached below and can be viewed directly.
Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| March 11, 2016 (Fri) 10:00–16:50 | Zendentsu Labor Hall (Zendentsu Hall) |
Information and Program
Event Notice and Program (293KB)
Lecture Materials
| Presentation | Speakers |
|---|---|
| 01_Overview of the Q3D Guidelines and Related Information (1193KB) | Chikako Shikata (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 (354 KB) | Takumi Ogawa (Expert, Q3D IWG, NIH) |
| Masayuki Mishima (Topic Leader, ICH Project Q3D IWG, Japan Pharmaceutical Manufacturers Association) | |
| Akihiko Hirose (National Institute of Health Sciences, Q3D IWG Topic Leader) |