EMA: Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits

This module provides guidance on planning and conducting the legally required audits, and in respect of the operation of the European Union regulatory network, the role, context and management of pharmacovigilance audit activity. This module is intended to facilitate the performance of pharmacovigilance audits, especially to promote harmonisation, and encourage consistency and simplification of the audit process.