Third industry stakeholder platform: operation of European Union pharmacovigilance legislation

The third platform meeting with industry stakeholder associations on the implementation and operation of the European pharmacovigilance legislation took place at the European Medicines Agency (EMA) on 13 March 2015. Discussion at the meeting focused primarily on pharmacovigilance information systems and services (including Article 57 product database, Eudravigilance, medical literature monitoring and the periodic safety report (PSUR) repository), the introduction of pharmacovigilance fees, as well as a review of experience with PSUR and referrals procedures. The meeting provided a valuable opportunity to obtain practical feedback on the available systems, processes and guidelines. Updates on post-authorisation safety studies (PASS) management through EMA scientific advice and upcoming activities on risk management plan (template and GVP XVI addendum updates) were also presented by the regulators.