Periodic Safety Update Report (PSUR)

  • PSURs are important pharmacovigilance documents applying to drugs already approved for marketing – regularly updating regulatory authorities on the worldwide safety experience of approved drugs.
  • A new format for PSURs, the PBRER (Periodic Benefit Risk Evaluation Report: ICH E2C (R2)), came into force in the European Union and European Economic Area on 2nd July 2012 – as the result of the European Medicines Agency (EMA) guidance on Good Pharmacovigilance Practices (GVP) issued in June 2012. The same PBRER format has also been adopted to replace PADERs in the United States.
  • Trilogy’s experience extends to more than 100 PSURs across an extensive range of indications.
  • Trilogy helps our clients’ pharmacovigilance departments identify new safety signals (if present), giving advice on the Marketing Authorisation Holder (MAH) response and communicating the key messages to reviewers in a clear and easy-to-understand manner.
  • PSURs must be submitted every 6 months after product authorisation until 2 years after the initial placing on the EU market, yearly for the following 2 years, and at 3-year intervals thereafter.
  • Trilogy can also arrange full clinical review and sign-off, produce Summary Bridging Reports as well as published literature summary and analysis, and provide suggestions for company comments.
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Pharmacovigilance
Dr. Lisa Chamberlain-James
(Senior Partner)