APEC AHC workshop, 4-5 October 2011, Seoul, Republic of Korea

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 the Rebublic of Korea. 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 welcomed 513 participants from APEC and non-APEC regions. Speakers included experts from FDA, PMDA, AFSSAPS, Pharmaceutical industry and the ICH Quality IWG.

This training event was organised by the APEC Harmonisation Center (AHC) and hosted by the Korea Food and Drug Administration (KFDA).

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...

4-5 October 2011 Seoul, Republic of Korea