14 March 2011

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 now available on the ICH website. This training package covers 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 training package also includes recordings from the US Quality IWG training workshop that was held in Washington D.C. in October 2010 to further facilitate comprehension on these topics.

All presentations are available on the following page on the ICH website: Integrated Implementation Training Programme for ICH Q8, Q9 and Q10