Workshop on the ICH M7, Q3D Guidelines (Zendentsu Hall, Tokyo)

The workshop on the ICH M7, Q3D Guidelines was held in Japan, which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on April 7, 2015.

This workshop was the opportunity to provide the detailed explanation of ICH Q3D: Guideline for elemental impurities and ICH M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. 

Approximately over 350 participants from not only pharmaceutical industries but also relevant industries attended this workshop and had vigorous Q&A discussion. 

This workshop on the M7, Q3D guidelines 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
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Location: Zendentsu Hall, 3-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan 
Date: April 7, 2015   10:00 am ~4:40 pm

The presentations in Japanese from the workshop are available on the JPMA website.

At a Glance...

April 7th, 2015 Japan