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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...

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Detalles Bibliográficos
Autores principales: Candore, Gianmario, Monzon, Sebastian, Slattery, Jim, Piccolo, Loris, Postigo, Rodrigo, Xurz, Xavier, Strauss, Sabine, Arlett, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
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