Manufacturing and Production

Pharmacovigilance and Post Market Safety

A medicine is approved on data from a few thousand patients and then used by populations large enough to reveal effects the trials could never have detected, which makes post market surveillance the only place some risks will ever be found. This course covers running that surveillance. Delegates work through the pharmacovigilance system and the responsibilities a marketing authorisation holder carries. Adverse event definitions are covered, including seriousness, expectedness and causality assessment. Case processing follows: intake from all sources, triage, data entry, medical review and the timelines for expedited reporting. Signal detection is addressed, including disproportionality analysis and the judgement that turns a statistical signal into an action. Risk management plans and minimisation measures follow. Periodic safety reports are covered. Product complaints and their interface with quality are addressed, since a complaint can be both. Inspection and audit of a pharmacovigilance system follow. The course closes on recalls and safety communication to prescribers and patients.