Periodic Benefit-Risk Evaluation Reports (PBRERs) Review

It is a well-known fact that continuous monitoring of safety and timely detection of adverse effects is crucial during the post-marketing phase of a drug. Consistent with international pharmacovigilance legislation, it is important to continuously analyse the relevant safety, efficacy, and effectiveness information throughout a product’s life cycle.

This benefit-risk assessment should be done promptly, as important findings occur, as well as periodically, to allow a comprehensive overall assessment of the accumulating data. Health authorities are requesting to detail these results in a Periodic Benefit-Risk Evaluation Report (PBRER) or a Periodic Safety Update Report (PSUR).

Based on clinical and epidemiologic findings, we can assist our clients in reviewing and preparing PBRERs or PSURs, while providing guidance on the product’s safety, effectiveness, limitation of use and alternative treatments of the product.