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  • 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...
  • EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations

    A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of information on medicines. The six-part course covers the basics of the EudraVigilance system, the regulatory underpinnings of the system, which definitions are used in the system, the submission of EudraVigilance Product Report Messages and how to enter data. Successful completion...