ICHPharmaceutical Regulations in Japan

Workshop on the ICH Q3D Guideline and Training Material (Zendentsu Hall, Tokyo)

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
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
(PDF 1193KB)
Chikako Yomota, NIHS
10:45-12:00 Elemental Impurity Risk Assessment / Control of
Elemental Impurities (PDF 2579KB)
Yuko Uenishi, JPMA
13:00-13:40 Considerations for Large Volume Parenterals /
Converting between PDEs and Concentration Limits
(PDF 354KB)
Takumi Ogawa, PMDA
13:40-14:10 Developing Acceptable Levels for Other Routes of
Administration (PDF 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 (PDF 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

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