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Pharmacovigilance

Abstract

Since July 2012, much EU pharmacovigilance regulation has been published so an outsider might rationally conclude that it would be easy to define what ‘best safety practices are’ now. However, what constitutes the global ‘best practice’ and whether we have achieved a consensus depends on your point of view within the system both hierarchically and geographically. As of 2012, it seems the harm from medicines in the EU has serious public health implications as the European Medicines Agency (EMA) repeatedly stated the following to justify revision of the pharmacovigilance (PV) legislation [1]:

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Acknowledgements

The author thanks Dr Michael Klepper, President and CMO of Drug Safety Navigator for his helpful comments.

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Authors and Affiliations

  1. NDA Regulatory Science Ltd, Grove House, Guildford Road, Leatherhead, Surrey, UK

    Brian Edwards

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Correspondence to Brian Edwards .

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Editors and Affiliations

  1. Uppsala Monitoring Centre, Uppsala, Sweden

    I. Ralph Edwards

  2. Uppsala Monitoring Centre, Uppsala, Sweden

    Marie Lindquist

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Edwards, B. (2017). Best Safety Practices Now and in the Future. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_5

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  • DOI: https://doi.org/10.1007/978-3-319-40400-4_5

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