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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).
FAQ: Periodic Benefit-risk Evaluation Report (PBRER)
What is a Periodic Benefit-risk Evaluation Report (PBRER)?
A PBRER is a document that provides a periodic assessment of the overall benefit-risk profile of a marketed medicinal product. It contains new or emerging information on the risks and benefits of the medicinal product and includes proposed actions to optimize the benefit-risk profile.
When is a PBRER needed?
A PBRER is required after the first marketing authorization is granted in any country for a medicinal product containing the active substance (ie, the International Birth Date) and is updated at predefined intervals throughout the product lifecycle to support the ongoing assessment of its benefit-risk profile.
Why is it challenging to prepare a PBRER?
The PBRER requires input from multiple disciplines, involves the analysis of large volumes of data, and needs to be prepared within strict regulatory timelines.
How can Emtex Life Science support the preparation of the PBRER?
Emtex Life Science can support the planning, coordination, and writing of PBRERs, helping teams to deliver high-quality reports within challenging regulatory timelines.
Why is professional medical writing support valuable for the PBRER?
Professional medical writers help combine multidisciplinary input into a high-quality document that clearly communicates the evolving benefit-risk profile of a medicinal product while ensuring consistency across related documents, such as Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs).