Periodic Safety Update Report (PSUR);
Periodic Benefit Risk Evaluation Report (PBRER)
- PSURs/PBRERs are important pharmacovigilance documents applying to drugs already approved for marketing – regularly updating regulatory authorities on the worldwide safety experience of approved drugs.
- The PBRER (Periodic Benefit Risk Evaluation Report: ICH E2C (R2)), format 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 with PSURs/PBRERs extends across a wide 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/PBRERs must be submitted every 6 months after product authorisation until 2 years after 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.
Dr. Lisa Chamberlain James