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Artificial intelligence (AI) has become a transformative force in the increasingly digitized healthcare environment. Pharmacovigilance (PV)u2014the science and practices pertaining to the identification, evaluation, comprehension, and avoidance of side effects or any other drug-related issuesu2014is one of the most revolutionary uses of AI in the pharmaceutical sector.<br>More Info: https://clival.com/blog/pharmacovigilance-in-the-age-of-ai
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Introduction Artificial intelligence (AI) has become a transformative force in the increasingly digitized healthcare environment. Pharmacovigilance (PV)—the science and practices pertaining to the identification, evaluation, comprehension, and avoidance of side effects or any other drug-related issues—is one of the most revolutionary uses of AI in the pharmaceutical sector.
The Rise of AI in Pharmacovigilance Pharmacovigilance has historically relied on clinical trials, electronic health records (EHRs), spontaneous reports, and regulatory databases to identify adverse drug reactions (ADRs). • Automated Adverse Event Detection • Signal Detection and Management • Case Triage and Report Automation • Global Literature Screening
The Risks: Is AI a Double-Edged Sword? • Algorithm Bias and Validation Challenges • Regulatory Uncertainty and Compliance Risks • Over-Reliance and Deskilling • Data Privacy and Security • Data Quality & Bias • Regulatory Gaps • Ethical Concerns
Global Harmonization of AI in Pharmacovigilance • Standardized Frameworks and Guidelines • Transparency and ExplainabilityRequirements • Cross-Border Data Sharing Agreements • Continuous Monitoring and Human Oversight
Conclusion AI gives a rage backbone for enhancing the productivity, speed, and accuracy of pharmacovigilance. But the road to adoption must be laid down carefully, with full awareness and consideration for others. Planning shows much promise for AI, but a balance in regulatory approaches will determine whether it becomes evolutionary success or a risk in pharmacovigilance. Instead of taking the position of human judgment, AI should be utilized as a tool to support patient care standards and improve the abilities of safety specialists.
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