Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Ugrapal Singh, Prof. Bindeshwari Prasad Gupta

Abstract: Pharmacovigilance plays a crucial role in ensuring the safety of pharmaceutical products by monitoring and assessing adverse drug reactions (ADRs) throughout their lifecycle. Traditional pharmacovigilance methods heavily rely on spontaneous reporting systems and clinical trials data. However, the advent of electronic health records (EHRs) and big data analytics has provided an opportunity to enhance pharmacovigilance through the incorporation of real-world evidence (RWE). This paper explores the evolving role of RWE in pharmacovigilance, emphasizing the utilization of EHRs and big data analytics for improved safety monitoring and regulatory decision-making.

Keywords: Pharmacovigilance, Real-World Evidence, Electronic Health Records (EHRs), Big Data Analytics, Drug Safety, Regulatory Decision Making, Patient-Centric Pharmacovigilance, Signal Detection, Predictive Analytics.