Signal Management in Pharmacovigilance: From Detection and Validation to Benefit-Risk Decisions and Regulatory Action

A practical, end-to-end guide to pharmacovigilance signal management, from the first statistical alert to the final regulatory decision.Most drug safety texts explain how to find a signal. Far fewer show what happens next: how a signal is validated, prioritized, assessed, weighed against benefit, escalated, and closed with a record that holds up. Signal Management in Pharmacovigilance covers that ...