Pharmacovigilance, once called drug safety, has changed significantly over the past years. Expectations of the public (in particular concerned patients) and regulators have had profound effects on structures, processes, outputs, as well as objectives of concerned parties involved in Pharmacovigilance. Including – but not limited to – Regulatory Affairs, Quality Management, Compliance, Clinical Research, and, of course, Pharmacovigilance (PV).

PV may have once been considered a liability. However, an effective and sustainable PV is clearly an asset: Able to protect patient safety, hence allowing for appropriate life cycle management. Able to monitor and minimize drug risks, including off label use, hence significantly reducing liability risks. Able to provide expert input into labels and other publically available product information, hence training health care professionals and patients alike.

Part of effective PV, and increasingly so since 2012, is a consistent PV Quality Management System, which is both sustainable and effective. This is a requirement, not an option. And it is tested thoroughly in PV inspections from regulators worldwide. An integral and essential part of that Quality Management System are PV audits, where all PV functions and many or most of the system components are checked. Thereby providing not only oversight (and insight) for the EU Qualified Person for Pharmacovigilance, but at the same time allowing for focus on the most essential changes that may be needed – as well as serving as an intense preparation for upcoming PV inspections.

Delegates will therefore learn and practice the elements of PV audits, both from the auditor as well as from the auditee’s side. They will be able to create and maintain a customized PV audit system, allowing for continual improvement as well as providing documented evidence for the appropriateness of the PV system – whether in the context of a new a drug application, before an inspection, or in the context of securing the distributorship contract.