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Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines

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Acknowledgements

The authors wish to acknowledge the constructive comments provided by Dionna Green and Ann McMahon from the Food and Drug Administration. The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated.

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Authors and Affiliations

  1. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy

    Janet Sultana

  2. Signal and Incident Management Service, Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands

    Cosimo Zaccaria

  3. Paediatric Medicines Office Product Development Scientific Support Department, European Medicines Agency, Amsterdam, The Netherlands

    Roberto de Lisa

  4. Department of Experimental Medicine, Pharmacology Division, University of Campania “L. Vanvitelli”, Naples, Italy

    Francesco Rossi, Annalisa Capuano & Carmen Ferrajolo

  5. Campania Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy

    Francesco Rossi, Annalisa Capuano & Carmen Ferrajolo

Authors
  1. Janet Sultana
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  2. Cosimo Zaccaria
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  3. Roberto de Lisa
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  4. Francesco Rossi
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  5. Annalisa Capuano
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  6. Carmen Ferrajolo
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Corresponding author

Correspondence to Carmen Ferrajolo.

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No sources of funding were used to prepare this manuscript.

Conflict of interest

Janet Sultana, Cosimo Zaccaria, Roberto de Lisa, Francesco Rossi, Annalisa Capuano and Carmen Ferrajolo have no conflicts of interest to declare.

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Sultana, J., Zaccaria, C., de Lisa, R. et al. Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines. Pediatr Drugs 21, 317–321 (2019). https://doi.org/10.1007/s40272-019-00350-w

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