By: Ashwini Tripathi -- Senior Research Analyst
30 June, 2014
Suspected Unexpected Serious Adverse Reactions (SUSARs) have become a critical element in analyzing the risk and benefit associated with a life cycle of medicinal product either in market or clinical trial. It has been a dynamic and swiftly changing area of the pharmaceutical industry and has become one of the concerns as well. In the past 3 to 5 years pharmacovigilance has witnessed 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. Stringent guidelines, patient awareness, pharmaceutical companies? interest in drug safety data increased the patient safety monitoring. Today, pharmaceutical industry is facing challenges due to increased reporting requirements to manage increased SUSARs reported. Pharmaceutical companies outsource SUSARs under the pharmacovigilance services to various suppliers based upon their geographical, product and service capabilities. The pharmaceutical companies maintain in house resources to ensure the quality of services for SUSARs reporting and maintenance.