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Drug Safety

, Volume 27, Issue 8, pp 499–508 | Cite as

Risk Management

A European Regulatory Perspective
  • Jane N. S. Moseley
Leading Article

Abstract

Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.

Keywords

European Union Medicinal Product Marketing Authorisation Orphan Medicinal Product Marketing Authorisation Application 
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

The views expressed are those of the author. This review does not constitute formal regulatory guidance. Relevant formal European guidance documentation and legislation as appropriate should be consulted for detailed pharmacovigilance obligations.

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Copyright information

© Adis Data Information BV 2004

Authors and Affiliations

  • Jane N. S. Moseley
    • 1
  1. 1.Pharmacoepidemiology Research Team, The Medicines and Healthcare products Regulatory Agency, Room 15-206 Market TowersLondonUK

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