A Review: Pharmacovigilance and Studies of Clinical Research for Health Care

Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and other medication-related risks. This review explores the evolution of pharmacovigilance, from its historical foundations to modern advancements in artificial intelligence, big data analytics, and real-world evidence (RWE). Key topics include global regulatory frameworks (e.g., WHO, ICH, FDA, EMA), methodologies for signal detection, risk management plans (RMPs), and the growing importance of patient-reported outcomes. Challenges such as underreporting, data quality, and globalization of drug markets are discussed, alongside emerging trends like digital pharmacovigilance and vaccine safety surveillance. The article underscores the need for robust PV systems to enhance public health and foster trust in therapeutic interventions.