Current Edition

SUSAR Consolidation New Procurement Approach in Pharmacovigilance

In the past three to five years, pharmacovigilance has witnessed a paradigm shift after release of guidelines by the US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) which has changed the way SUSARs have been managed. Pharmaceutical companies outsource SUSARs under the pharmacovigilance services to various suppliers based upon their geographical, product and service capabilities. Ashwini Tripathi, Senior Research Analyst of Voisin Consulting, explains how Suspected Unexpected Serious Adverse Reactions have become a critical element in analysing the risk and benefit associated with a life cycle of medicinal product either in the market or clinical trials.