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Lifecycle of a Safety Signal
In pharmacovigilance, the identification of a potential safety signal is the beginning of a structured scientific and regulatory process—not the conclusion. A safety signal may arise from spontaneous…
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GVP
4 articles
Are You Ready for Your Next Drug Safety Inspection?
Pharmacovigilance (PV) inspections are no longer viewed as isolated regulatory events—they are an essential mechanism for ensuring that Marketing Authorization Holders (MAHs) maintain effective pharmacovigilance systems that protect…
Effective Signal Management: Bridging Data Detection and Regulatory Action
In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs requirements. It goes beyond…
Integrating Real-World Data into Pharmacovigilance Systems
Pharmacovigilance (PV) has traditionally relied on spontaneous reporting systems, clinical trial data, and published literature to monitor the safety of medicinal products. However, the increasing availability of real-world…
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