SMU Medical Journal

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This article is an overview of the process of aggregate reporting in pharmacovigilance where the main characteristics of PSUR are presented. 2012 is a crucial moment of the safety reporting when some changes were made and which reflect the main point of the evaluation of the reports-from detailed line-listings of the adverse drug reactions to the cumulative summaries of the serious adverse events, mainly in clinical trials, and the main approach, which is the evaluation of the risk/benefit balance. This leads to discovering new indications of the drugs and a proposal for changes in Summary of Product Characteristics of the observed medications.

Keywords

PSUR, PBRER, Pharmacovigilance, Risk/Benefit Evaluation.
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