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Session 2: Oversight Session – Building Blocks of a Compliant PV System
Session Chair(s)
Ilaria Grisoni, MSC
Executive Director, Head of International QPPV Office, EEA QPPV, Jazz Pharmaceuticals, Italy
Angela Van Der Salm, PHD, MSC
Director PV, Managing partner, DADA Consultancy B.V., Netherlands
This session focusses on several areas that feed into QPPV (office) oversight of the operational aspects of the PV system. As a popular recurring topic, this year we are looking at it from a different angle, peeling off the multiple layers that compose a PV system. We start at the PV department, then look at neighboring functions (Marketing/Regulatory/ClinOps/Quality/etc), and then at all the outsourced activities. Who keeps oversight on what (e.g. what if the service provider further subcontracts specific activities to another third party)? When is who informed?
Speaker(s)
Rory Littlebury
Head of PVSO and QPPV Office, GlaxoSmithKline (GSK), United Kingdom
How does the QPPV have oversight over the Local QPPV?
Lene Holdrup, MSC
Senior Director, QPPV, Ferring Pharmaceuticals A/S, Denmark
How does the QPPV ensure oversight of neighboring functions?
Ana Pedro Jesuíno
Director, Local QPPV Network - Global Head, IQVIA, Portugal
How does the QPPV ensure oversight of insourced activities (outsourced to a subcontractor)?