European legislation such as Volume 9A requires all marketing authorisation holders to have one qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company's global pharmacovigilance system. Although acknowledged to be a vital function, there is little practical guidance on how QPPV responsibilities should best be conducted, while maintaining compliance with regulatory requirements. The jurisdiction of the QPPV stretches to wherever there is an active licence for a product authorised in the EU. Thus the role in many companies has a global impact. During this meeting we will discuss and advise on current practice to help QPPVs perform their job more efficiently.
Learning Objectives:
• To evaluate the place of the QPPV in the Future Strategy for the EU Pharmacovigilance System
• To share experiences to learn better how to fulfil and deal with the role of the QPPV
• To understand the challenges of being a QPPV for Small & Medium Enterprises and contractually within CROs
• To advance understanding of the legal aspects for the QPPV
• To enable QPPVs to articulate their role in the company in order to promote senior management understanding and support
• To build on initiatives from the QPPV Forum 2008.
Learning Objectives:
• To evaluate the place of the QPPV in the Future Strategy for the EU Pharmacovigilance System
• To share experiences to learn better how to fulfil and deal with the role of the QPPV
• To understand the challenges of being a QPPV for Small & Medium Enterprises and contractually within CROs
• To advance understanding of the legal aspects for the QPPV
• To enable QPPVs to articulate their role in the company in order to promote senior management understanding and support
• To build on initiatives from the QPPV Forum 2008.
