Expert Circles

PIC/S has formed several "Expert Circle" groups with the aim to enable Inspectors to discuss and exchange information on specific technical areas of GMP; develop draft guidance documents (including new Annexes to the GMP Guide); and provide for training opportunities in their field of expertise.

 
Expert Circle meeting on APIs, hosted by EDQM, Strasbourg (France), 2015
 

Key Features

Akin to Seminars, meetings of Expert Circles are organised on a regularly basis by PIC/S Participating Authorities.  Each Circle has a Co-ordinating Committee which is responsible for steering the Circle and organising future meetings in line with the PIC/S Guideline for Expert Circles. Attendance and the length of the meetings vary between Expert Circles. Each Expert Circle reports to the PIC/S Sub-Committee on Expert Circles (SCEC).

Expert Circle meetings should normally not last longer than Seminars (2.5 days).  To the extent possible, a clear distinction is made in the Expert Circle programmes between (i) the drafting of guidance documents; (ii) experts discussions and (iii) training. The presentations and video-recordings (where applicable) made during Expert Circle training activities are compiled and made available to participants and PIC/S Members after the event (see Materials).

The following PIC/S Expert Circles are currently active and meet regularly:


 

Active Pharmaceutical Ingredients

The PIC/S Expert Circle on Active Pharmaceutical Ingredients (API) was established in 2005. It has been active in developing and maintaining a common approach and equivalent interpretation of the ICH Q7 Guideline...

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Computerised Systems

The PIC/S Expert Circle on Computerised Systems was established in 2002. It has been active in the training of inspectors in the inspection of computerised systems for GXP inspections...

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Good Distribution Practice

The PIC/S Expert Circle on Good Distribution Practice (GDP) was established in 2013. It has been very active in the training of inspectors by providing advanced training courses imparting GDP inspectors with...

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Human Blood, Tissues, Cells & ATMPs

The PIC/S Expert Circle on Human Blood, Tissues, Cells & ATMPs was established in 1994. It has been very active in the training of inspectors in the field of blood, blood components, plasma derivatives, cells... 

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Quality Risk Management

The PIC/S Expert Circle on Quality Risk Management (QRM) was established in 2007. It has been active in developing models for QRM systems for inspectorates as well as guidance on the assessment of QRM implementation in industry...

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Working Group on Good Clinical and Good Pharmacovigilance Practices

The  PIC/S Working Group on Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV) was established in 2014. It stems from interest expressed by a number of... 

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