IDEAS home Printed from https://ideas.repec.org/p/smo/raiswp/0209.html
   My bibliography  Save this paper

The Role of EudraVigilance in Protecting and Promoting Public Health in the European Economic Area in the Context of the SARS-CoV-2 Pandemic

Author

Listed:
  • Cristina-Luiza Erimia

    (Ovidius University of Constanta, Constanta, Romania)

  • Radu George Cazacincu

    (Ovidius University of Constanta, Constanta, Romania)

  • Verginica Schroder

    (Ovidius University of Constanta, Constanta, Romania)

Abstract

The EudraVigilance database is the central pillar for pharmacovigilance activities in the European Economic Area. The reporting of adverse reactions in the EEA through the EudraVigilance system enables the management of reported data and the analysis of adverse medicine reactions, with the information being available anywhere in the EEA. This article aims to analyze, on the one hand, the EU legislation on pharmacovigilance, the key activities and developments that will take place through the implementation of the EudraVigilance Operational Plan 2020–2022, a document launched by the European Medicines Agency to ensure the sustainability of EudraVigilance and the associated actions in support of EU pharmacovigilance and public health protection activities. On the other hand, the article aims to analyze how, in accordance with a specific pharmacovigilance plan and using the EudraVigilance system, the EMA and the national competent authorities (NCA) of the EU member states have monitored suspected adverse reactions to the COVID-19 vaccines, thereby contributing to the protection of the health of European citizens.

Suggested Citation

  • Cristina-Luiza Erimia & Radu George Cazacincu & Verginica Schroder, 2022. "The Role of EudraVigilance in Protecting and Promoting Public Health in the European Economic Area in the Context of the SARS-CoV-2 Pandemic," RAIS Conference Proceedings 2022-2024 0209, Research Association for Interdisciplinary Studies.
    • Handle: RePEc:smo:raiswp:0209
    as

    Download full text from publisher

    File URL: https://rais.education/wp-content/uploads/2022/09/0209.pdf
    File Function: Full text
    Download Restriction: no
    ---><---

    More about this item

    Keywords

    EU pharmacovigilance legislation; EudraVigilance; public health; European Economic Area; COVID-19 vaccines;
    All these keywords.

    NEP fields

    This paper has been announced in the following NEP Reports:

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:smo:raiswp:0209. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Eduard David (email available below). General contact details of provider: http://rais.education/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.