what is aggregate reporting
Aggregate reporting in pharmacovigilance refers to the periodic evaluation and documentation of safety data collected from multiple sources over a specific timeframe. Unlike individual case safety reports (ICSRs), aggregate reports analyze patterns and trends across a group of reports to detect potential risks associated with a drug. These reports—such as Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs)—help regulatory authorities and pharmaceutical companies assess the overall benefit-risk profile of a medicine. Aggregate reporting plays a crucial role in ensuring drug safety and supports informed regulatory decisions.