Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

The Quality system is becoming an integrated part of the PV system. Audits and inspections play a major role in a quality system and PV inspections are a common sight in many markets today, both in and outside the EU. This brings new challenges for industry in terms of managing multiple inspections and findings and underlines the overall goal of supporting solid and accurate PV systems. What are the challenges for industry when it comes to multiple PV inspections, what are inspectors’ experiences and how are our findings exchanged? This session will focus on inspections, with a session on local inspections, a session on the PV Inspectorate Working Group and the experience of a Saudi Inspection. Throughout the presentations some general thoughts on how findings are discussed and shared will be provided. Sharing the learnings from inspections will benefit PV systems and strengthen collaboration and dialogue with inspectors. In addition, it may enable QPPVs to focus their efforts and collaborations on certain areas of their PV system.