The Qualified Person for Pharmacovigilance for EuropeA Compliance and Quality Perspective

A decade after the legal requirement for a qualified person (QP) for pharmacovigilance for Europe for each pharmaceutical company was promulgated, the exact obligations of the QP remain contentious. This paper reviews the responsibilities of the QP, as set out in legislation and guidelines, pointing out ambiguities and uncertainties, and provides an interpretation of these. The wide-ranging remit of the QP presents many challenges for the incumbent, not least of which is how one individual can take personal responsibility for multiple activities taking place across several countries. The answer may lie in the institution of a number of inter-related capabilities: delegation of activities to trained individuals, while retaining responsibility; oversight of activities involving drug safety; awareness of what is happening in the company that could have an effect on benefit and risk; and personal involvement in certain key pharmacovigilance activities. A robust quality assurance and control operation is vital, with the QP being central to this process.