AGGREGATE REPORTS

Taking emerging adverse events in its ambit, Aggregate reports (PSURs/PBRERs/DSURs) aim to provide a comprehensive and critical analysis of the risk-benefit balance of the product. They periodically create the golden opportunity for an overall safety re-evaluation thus providing an insight into any investigations or any changes which need to be made to the product information. Several sources contribute to the formation of the aggregate reports viz. Spontaneous reports, observational studies, and data from clinical and non-clinical studies to mention a few. In light of the complexity of the document and the exacting and inflexible regulations, the preparation of aggregate reports of the highest quality and timely submission is a major challenge globally