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The Qualified Person for Pharmacovigilance for Europe

A Compliance and Quality Perspective
  • Elliot G. BrownEmail author
Leading Article

Abstract

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.

Keywords

European Union Competent Authority Marketing Authorisation Qualified Person Adverse Event Report 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

Dr R Chipperfield, for assistance with background material.

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Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  1. 1.BarnetUK

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