safety aggregate reporting
Safety aggregate reporting is a critical function in pharmacovigilance, focusing on the periodic evaluation of drug safety data. Unlike individual case reports, aggregate reports compile and analyze data from multiple sources over a defined period to identify safety trends, risks, and potential signals. Key types include Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). These reports help regulatory authorities assess the overall benefit-risk profile of a medicinal product, ensuring patient safety and informed regulatory decisions.