ICH Quality IWG workshop, 2-4 June, 6-8 October and 27-29 October 2010, respectively in Tallinn, Washington DC and Tokyo

October 2010 saw the completion in the three ICH regions of Europe, US and Japan of a unique quality training programme provided by the ICH Quality Implementation Working Group. The series of training workshops kicked-off in Tallinn on June 2-4, and was followed by training in Washington D.C. and Tokyo on October 6-8 and October 25-27 respectively. The objective of these workshops was to assist with efforts to ensure the consistent implementation of ICH’s most recent quality guidelines: ICH Q8 on Pharmaceutical Development; ICH Q9 on Quality Risk Management; and ICH Q10 on Pharmaceutical Quality System. These guidelines have contributed to a new quality paradigm, with a departure from traditional approaches to quality guidance.

Participants to these workshops, who numbered close to 1,000 in total, were informed on topics such as technical development, manufacturing details, and pharmaceutical quality systems, as well as regulatory aspects including regulatory expectations, dossier preparation, assessment and GMP-inspections.

The workshops were co-sponsored in Europe by Parenteral Drug Association (PDA), in the US by the International Society for Pharmaceutical Engineering (ISPE), in Japan by JPMA (Japan Pharmaceutical Manufacturers Association) and PMRJ (Pharmaceutical and Medical Device Regulatory Science Society of Japan).

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.

At a Glance...

2-4 June 2010, 6-8 October and 25-27 October 2010 Tallinn, Estonia, Washington DC, US, Tokyo, Japan