Japanese ICH Quality IWG workshop follow up, 25 April 2011, Tokyo, Japan

Following the completion of the first integrated implementation training workshop for ICH Q8, Q9 and Q10 in October 2010, a follow up training was organised in Japan for a second opportunity to participate in this training on the future of pharmaceutical development, manufacturing and quality. This workshop provided comprehensive information on the integrated implementation of ICH Q8, Q9 and Q10 Guidelines in technical development, manufacturing details and pharmaceutical quality systems, as well as in regulatory aspects including regulatory expectations, dossier preparation, assessment and GMP-inspections.

This Japanese follow up event was co-sponsored by JPMA (Japan Pharmaceutical Manufacturers Association) and PMRJ (Pharmaceutical and Medical Device Regulatory Science Society of Japan). This event was open to regulatory and industry expert.

The presentation in Japanese from the first regional integrated training workshop conducted in Japan in October 2010 are available on the JPMA website.

To extend the benefits of the three ICH regional workshops on the ICH Q8/Q9/Q10 Guidelines held in 2010, in Europe, Japan and the US, the Quality Implementation Working Group has developed a consolidated training package that is available on the ICH website: Integrated Implementation Training Programme for ICH Q8, Q9 and Q10.