ICH Project Workshop on the ICH Q3D Guideline and Training Material (Zendentsu Hall, Tokyo)
March 11, 2016
The workshop on the ICH Q3D Guideline and Training Material was held in Japan, which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on March 11, 2016.
This workshop was the opportunity to provide the detailed explanation of ICH Q3D: Guideline for elemental impurities. Approximately over 250 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion.
This workshop was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association. All the presentation used at the workshop is available in Japanese as below.
- Working Language
- Japanese
None of this publication may be reproduced by any means without the prior permission of the copyright owner.
- Location
- Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
- Date
- March 11, 2016 10:00 am ～4:50 pm
| Presentation materials | Speakers | |
|---|---|---|
| 10:00-10:05 | Opening remarks | Hironobu Saito, JPMA |
| 10:05-10:45 | Overview and Related Information on Q3D Guideline (1193KB) | Chikako Yomota, NIHS |
| 10:45-12:00 | Elemental Impurity Risk Assessment / Control of Elemental Impurities (2579KB) | Yuko Uenishi, JPMA |
| 13:00-13:40 | Considerations for Large Volume Parenterals / Converting between PDEs and Concentration Limits (354KB) | Takumi Ogawa, PMDA |
| 13:40-14:10 | Developing Acceptable Levels for Other Routes of Administration (193KB) | Masayuki Mishima, JPMA |
| 14:10-15:00 | Justification for Elemental Impurity Levels Higher than an Established PDE / Developing an Acceptable Level for an Elemental Impurity not in Q3D (435KB) | Akihiko Hirose, NIHS |
| 15:10-15:30 | Case Studies | Takumi Ogawa, PMDA |
| 15:30-16:00 | FAQ | Akiko Ugi, PMDA |
| 16:00-16:50 | Q&As on the Q3D Guideline and Training Material | ICH Q3D EWG/IWG Members |