Published Paper Details:

Pharmacovigilance is a critical field that focuses on the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related problems. This discipline plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle, from pre-marketing clinical trials to post-marketing surveillance. The rapid advancement in drug development and the increasing complexity of therapeutic options necessitate robust pharmacovigilance systems to monitor the risks and benefits of medications in real-world populations. Despite extensive regulatory frameworks and global collaboration, underreporting of ADRs and challenges in data integration remain significant barriers. This review paper explores the fundamental concepts of pharmacovigilance, including adverse drug reaction reporting systems, risk management strategies, and the evolving role of technology in improving safety monitoring. The paper also examines the regulatory frameworks established by agencies such as the FDA, EMA, and WHO, and highlights the importance of continuous monitoring to detect previously unrecognized safety concerns. The growing use of artificial intelligence and big data analytics in pharmacovigilance is also discussed, offering a glimpse into the future of drug safety assessment. Ultimately, pharmacovigilance serves as a critical tool for optimizing patient safety, guiding clinical decision-making, and contributing to the development of safer, more effective therapies. Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) or any other drug-related problems. It aims to improve patient safety and ensure the safe use of medicines by monitoring their effects in real-world settings after they have been approved and are available on the market.