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Update from PIC/S Meeting in Geneva

The PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Sub-Committee on Training Meeting took place in Geneva between 28-30 May 2013. The main topics that were discussed are summarized below.

A new Sub-Committee structure of PIC/S will enter into force on 1 January 2014. It foresees a more participative and efficient organisation where each Sub-Committee will be responsible for its respective core areas and will take the lead in developing policies.

The new structure includes seven Sub-Committees, which will be open to Members of the PIC/S Committee as well as to inspectors from PIC/S Participating Authorities, in the following fields:

  • Training (SCT)
  • Expert Circles (SCEC)
  • Strategic Development (SCSD)
  • Compliance (SCC)
  • GM(D)P Harmonisation (SCH)
  • Budget, Risk and Audit (SCB)
  • Communication (SC COM)

The process of nominations to the various Sub-Committees has been initiated and will be finalised during the second half of 2013.

The Committee also decided to establish a Working Group composed of Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) inspectors as well as further investigation into the potential establishment of a PIC/S Inspectorates’ Academy to provide cost-efficient, primarily web-based, high quality harmonised training for Inspectorates.

With respect to sharing of information, PIC/S Members and Partners discussed further improvements and benefits in connection with the process of maintaining and updating PIC/S’ list of planned foreign inspections, with a view to better facilitate the sharing of inspection findings, avoid any unnecessary duplication, enhance synergies, maintain mutual confidence and offer a reply to the expectations of the industry.

The document is available on the PIC/S GMP in Geneva website.

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Benefits of PIC/S Membership for regulators and industry.