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  • EMA Finalizes Pharmacovigilance Practice Guidelines

    The European Medicines Agency (EMA) has released seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be-implemented pharmacovigilance (PV) legislation, which comes into effect 2 July 2012. The modules cover a variety of topics, including PV systems, PV quality systems, risk management systems, PV system master files, Periodic safety update reports (PSURs), postmarketing safety studies and advers...
  • EMA Releases Presentations, Videos from Pharmacovigilance Stakeholder Meeting

    The European Medicines Agency (EMA) today (2 April) released video and presentations from its fourth stakeholder forum on the implementation of the new pharmacovigilance legislation. The meeting was held 27 February 2012, and heard presentations from members of EMA, the European Commission, the Irish Medicines Board, the Finnish Medicines Agency and the Medicines and Healthcare products Regulatory Agency. The presentations included: Welcome and introduction - June...