Pharmacovigilance in Clinical Trails

Abstract

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug- related problems, is intrinsically linked to effective information management. The pivotal role of information in pharmacovigilance encompassing data collection, analysis, and dissemination for optimal patient safety. The foundation of pharmacovigilance lies in robust information system that facilitate the collection of adverse event reports from health-care professionals, Patients, and other stake holders’ Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. A critical component throughout the drug development life- cycle is monitoring patient safety.