Navigating the Periodic Benefit Risk Evaluation Report

The Periodic Benefit Risk Evaluation Report (PBRER) is the international standard for aggregate safety reporting under ICH E2C (R2) guidelines. It represents a shift from simple safety reporting to a more holistic benefit-risk assessment.

Evolution from PSUR to PBRER

While many still use the terms interchangeably, the Periodic Benefit Risk Evaluation Report focuses more on the clinical benefit of the drug in relation to its risks. It requires a more integrated medical analysis than the older PSUR format.

When drafting a Periodic Benefit Risk Evaluation Report, it is vital to include data from all sources, including clinical trials, observational studies, and spontaneous reports.