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, particularly in complex or challenging situations. 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.
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