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Aggregate reporting in pharmacovigilance involves the periodic collection and analysis of drug safety data to assess the overall benefit-risk profile of a medicinal product. These reports summarize adverse drug reactions (ADRs) and other safety information over a specific time period. Common aggregate reports include Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). The objective of aggregate reporting is to ensure ongoing monitoring of drug safety, identify potential safety concerns, and comply with regulatory requirements for better patient safety. [ Link Details ]

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