11th Annual Forum for Qualified Persons in Pharmacovigilance

The QPPV is important in directing the interpretation of pharmacovigilance legislation and guidance. QPPVs have considerable flexibility but the basis of the decision must be transparent and properly documented. QPPVs must be able to explain the rationale of why a process is set up in a certain way or whether further changes are required to produce a compliant process. Challenges for quality include obtaining cross-functional ownership of issues and ensuring that all root causes remained addressed by corrective and preventive action plans. This session will explore the different experiences of the MAHs systems that both inspectors and auditors have recently had, how their activities have been supported by the QPPV and how they might expect the MAH to approach human error, communications between departments and other options, apart from audit, that the MAH might use to assess quality.