Authors : Sandesh U. Sutar; Prathamesh T. Patil; Shubham S. More; Gururaj D. Patil; Tejashree S. Khamkar

Volume/Issue : Volume 10 - 2025, Issue 10 - October

Google Scholar : https://tinyurl.com/yvxh26dt

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DOI : https://doi.org/10.38124/ijisrt/25oct898

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Abstract : Pharmacovigilance is essential to guaranteeing the effectiveness and safety of pharmaceuticals. This study highlights developments in signal identification, risk management, and minimisation techniques while giving a broad overview of current trends and potential future directions in pharmacovigilance. The growing significance of machine learning, artificial intelligence, and real-world evidence in pharmacovigilance is covered in the article. Updates to regulations are also reviewed, such as the US Food and Drug Government's (FDA) Safety Management and Critical Event Reporting rules and the European Pharmaceuticals Agency's (EMA) Good Regulatory Practices. Additionally, this review examines new pharmacovigilance potential and problems, including: The increasing demand for safety monitoring in personalised medication; The combination of precision medicine and pharmacogenomics Social media and digital health tools' effects on reporting adverse events; The changing roles of patients and medical professionals in pharmacovigilance.

Keywords : Regulatory Compliance, Risk Management, Drug Monitoring, Adverse Drug Reactions (ADRs), Drug Safety, Signal Detection, Real-World Data (RWD), Pharmacovigilance, and Post-Marketing Surveillance.

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