Marcus L. Davenport
Pharmacovigilance (PV) is the science and set of activities
dedicated to the detection, assessment, understanding,
and prevention of adverse effects or any other drugrelated
problems. It is an essential component of public
health, ensuring that the benefits of medications outweigh
their risks. PV spans pre-marketing clinical trials, postmarketing
surveillance, and the continuous reevaluation
of drug safety profiles. Regulatory authorities such as
the U.S. Food and Drug Administration (FDA), European
Medicines Agency (EMA), and the World Health Organization
(WHO) coordinate PV systems globally. The increasing
complexity of modern therapies, including biologics and
gene therapies, makes robust PV frameworks more crucial
than ever.
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