aggregate reporting in pharmacovigilance
Aggregate reporting in pharmacovigilance involves the periodic analysis and submission of safety data for a drug or vaccine over a defined timeframe. Unlike individual case reports, aggregate reports assess trends, risks, and benefit-risk profiles by compiling multiple adverse event reports. Key types of aggregate reports include Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs). These reports help regulatory authorities and pharmaceutical companies monitor drug safety, detect new risks, and ensure public health protection.