ICH Quality IWG workshop, 26-27 September 2011, Ottawa, Ontario, Canada

Following the completion of the first series of integrated implementation training workshops for ICH Q8, Q9 and Q10 in Europe, Japan and US in 2010, a similar workshop was organised in Canada. This workshop was intended to provide 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.

The workshop was open to all persons having interest in practical implementation of ICH Q8, Q9 and Q10, including regulators (assessors and GMP-inspectors) and industry (development, manufacturing, quality and regulatory affairs).

This training event was co-sponsored by Health Canada and the Canadian Society for Pharmaceutical Sciences (CSPS).

To extend the benefits of the different workshops conducted on the ICH Q8/Q9/Q10 Guidelines, 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.

At a Glance...

26-27 September 2011 Ottawa, Ontario, Canada