What are the core components of a pharmacovigilance plan, and how is signal detection typically conducted?

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Understanding pharmacovigilance planning starts with how safety signals are found and then managed. Signal detection is typically done by collecting spontaneous adverse event reports from clinicians, patients, and other sources, and by analyzing safety databases and the medical literature to spot potential safety signals. When a signal emerges, a formal risk assessment evaluates how likely it is that the drug caused the event, the seriousness and frequency of the event, and the potential impact on patients. This informs risk management planning, which specifies actions to minimize risk—such as updating labeling, issuing safety communications, or implementing other mitigation measures—and sets up follow-up monitoring to see if the measures work. Throughout, communication with regulators, healthcare professionals, and patients is essential to share safety information and support informed decisions.