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A Periodic Benefit-risk Evaluation Report (PBRER) gives an appraisal of the overall benefit-risk profile of a medicinal product. The purpose of the PBRER is to present periodic benefit-risk evaluation reporting on marketed products (in contrast to the DSUR, which reports safety information on drugs under investigation).
The PBRER contains new or emerging information on the risks (in approved and non-approved indications) and benefits (in approved indications only) of the medicinal product and includes proposed actions to optimize the benefit-risk profile. The PBRER format replaces the Periodic Safety Update Report (PSUR) format.
PBRERs are submitted to local authorities at specified time intervals. Starting from the international birth date (ie, the date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world), a PBRER is submitted every 6 months, annually, or less frequent, depending on local regulatory requirements and on how long the product is marketed. Changes in reporting frequency are possible after important additions or changes in clinical use (eg, new indication). The data lock point (DLP) marks the end of the PBRER reporting period and is the cut-off date for data in the PBRER.
The PBRER is a complex pharmacovigilance document that requires input from a multidisciplinary team. For any findings, the right level of detail (ie, proportional to the significance of the findings) should be included. Given the high reporting frequency and limited production time, the development of this document may be quite challenging.
The Medical Writer’s role is crucial in planning, managing, and writing of the document. It is key to ensure consistency across all PBRER sections and also across different pharmacovigilance documents (DSUR, RMP, PSUR/PBRER).