aggregate reporting
Aggregate reporting is a key component of pharmacovigilance, focusing on the periodic analysis and evaluation of drug safety data. It involves the compilation of safety information from multiple sources, such as clinical trials, post-marketing surveillance, and adverse event reports. The goal is to identify trends, patterns, and potential risks associated with a drug or medical product over time. Common types of aggregate reports include Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). These reports help regulatory authorities and pharmaceutical companies ensure patient safety and maintain compliance with global safety standards.