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The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
INTRODUCTION AND OBJECTIVE: European Union legislation has mandated the submission of European Economic Area non-serious reports to the EudraVigilance database since November 2017. As spontaneous reports of suspected adverse reactions to medicines represent a key source of safety signals, the Europe...
Autores principales: | Candore, Gianmario, Monzon, Sebastian, Slattery, Jim, Piccolo, Loris, Postigo, Rodrigo, Xurz, Xavier, Strauss, Sabine, Arlett, Peter |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8763735/ https://www.ncbi.nlm.nih.gov/pubmed/34881404 http://dx.doi.org/10.1007/s40264-021-01137-0 |
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