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PRAC - Pharmacovigilance Risk Assessment Committee

Before the Good Pharmacovigilance Practices came into effect in July 2012, we had the Pharmacovigilance Working Party, or PhVWP.

The PhVWP held its last meeting in July 2012, when the new Pharmacovigilance Risk Assessment Committee, or PRAC came into operation.

Role of the PRAC in Pharmacovigilance Inspections

  • The PRAC may make recommendations on the need and scope of "for cause" pharmacovigilance Inspections related to medicinal products of community interest.
  • The PRAC may, in relation to issues of community interest and where considered appropriate, review the outcome of pharmacovigilance inspections and assess marketing authorisation holder-related corrective and preventative action plan submission(s) in order to make or endorse further recommendations on actions to be taken and their follow-up.
  • The PRAC is also responsible for providing input in the preparation of and agreeing on the risk-based programme for routine pharmacovigilance inspections of marketing authorisation holders with centrally authorised products
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