• EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee

    The European Medicines Agency (EMA) has announced the appointment of the chair and vice chair of its newest committee, the Pharmacovigilance Risk Assessment Committee (PRAC), which is set to oversee newly implemented pharmacovigilance measures in the EU. The PRAC was formed to replace the now-defunct Pharmacovigilance Working Party (PHVWP). In a July statement, EMA said the PHVWP had completed its original charge, which was in its possession since the agency's founding...
  • EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee

    The European Medicines Agency (EMA) announced today (26 July) the release of two additional guidelines on good pharmacovigilance practices (GPhVPs) and the shuttering of its Pharmacovigilance Working Party. In a statement , the agency said the working party has been phased out of its original charge-given to it at the time of the agency's founding in 1995-to provide advice on the safety of medicines. Its duties will now be absorbed by a newly-established Pharmacovigila...