A joint Committee meeting of the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) took place in Krakow (Poland) on 26-27 May 2008.

It was followed by the annual PIC/S training seminar on “Good Distribution Practices as one of the Key Elements for Quality of Medicinal Products” (Krakow, 28-30 May 2008). The seminar was attended by around 120 participants from 40 countries.

The PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-2) has been revised in order to correct a misprint at Annex 1.

The revised Guide entered into force on 1 April 2008.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMEA) have agreed to strengthen their co-operation in the field of Good Manufacturing Practice (GMP) with a view to sharing resources and avoiding the duplication of activities.

To this end, the PIC/S Chairman and the Executive Director of EMEA signed on 22 December 2007 a co-operation agreement between their respective organisations in the form of an exchange of letters. The agreement covers areas of common interest, in particular the training of GMP inspectors, the exchange of information on guidance documents and audits of GMP inspectorates.

The Seminar was preceded by the PIC/S Committee meeting (19 November 2007). For the summary of main discussions and decisions see attached Press Release.

PIC/S- ASEAN FORUM (22 November 2007)
For the first time in PIC/S history, a meeting took place in Singapore between Regulatory Authorities of PIC/S and those of ASEAN. The meeting was dedicated to the identification of possible areas of co-operation.

ISPE - PIC/S WORKSHOP
Breaking traditions with the past, PIC/S has organised - jointly with ISPE - a workshop for both Regulators and Industry on “Systems Approach to Quality Risk Management”. It was attended by more than 226 participants (among which, 65 participants from Regulatory Authorities) representing 34 countries.