Expert Circles

Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of information among Inspectors specialised in a specific area of GMP such as Blood, Computerised Systems, Active Pharmaceutical Ingredients, Quality Risk Management, etc. Expert Circles meet regularly to develop draft guidance, recommendations, etc. and offer training in their respective fields of specialisation.

PIC/S Expert Circle meeting on API, Strasbourg (France), 2015

Sub-Committee on Expert Circles (SCEC)

Until 2013, the training activities of Expert Circles were monitored by the Sub-Committee on Training (SCT) while the activities related to guidance documents were placed under the direct supervision of the PIC/S Committee. With the new SC structure and considering the increase of activities of Expert Circles, it was decided to establish a specific SC: the Sub-Committee on Expert Circles (SCEC).  The main task of the SCEC is to review the composition and functioning as well as the various mandates of the Expert Circles.

The SCEC is currently chaired by Ms Kathleen Sinninger (US FDA) under which the following current Expert Circles and Working Groups operate:

• Active Pharmaceutical Ingredients
• Good Distribution Practice
• Human Blood, Tissues, Cells & ATMPs 
• Quality Risk Management 
• Control of Cross-Contamination in Shared Facilities
• Good Pharmacovigilance Practices
• Good Clinical Practices
• Working Group on Veterinary Medicinal Products (VMP)
• Working Group on Computerised Systems

The mandate of the SCEC is to: 

1. Identify the need to create / terminate Expert Circles;
2. Co-ordinate and monitor activities and meetings of Expert Circles;
3. Ensure that activities of Expert Circles are in line with their respective mandates, as approved by the PIC/S Committee, as well as with the Guidelines for PIC/S Expert Circles (PI 022);
4. Review the planning and organisation of Expert Circles meetings, in particular:
   • validate the yearly objectives as well as meetings’ objectives,
   • review the programme,
   • assess the meeting report,
   • make recommendations for future meetings,
   • ensure that Guidelines on Expert Circles are implemented / adhered to,
   • propose amendment to the Guidelines on Expert Circles;
5.  Report back to the PIC/S Committee, as provided for in the Terms of References and make proposals / recommendations.