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, preparation of aggregate reports of the highest quality and timely submission is a major challenge globally.
Why AWINSA?
Pharmacovigilance is dynamic and challenging discipline. Robust knowledge of the regulatory requirements needs to go hand in hand with sharp acumen for formulating flawless periodic reports. Our team has in depth knowledge of regulatory requirements honed by years of experience which will ensure the smooth sail of your facility even amidst turbulent regulations.
