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Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

INTRODUCTION: In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally...

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Detalles Bibliográficos
Autores principales:	Essink, Sharon C. M., Zomerdijk, Inge M., Straus, Sabine M. J. M., Gardarsdottir, Helga, De Bruin, Marie L.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2023
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10584707/ https://www.ncbi.nlm.nih.gov/pubmed/37658281 http://dx.doi.org/10.1007/s40264-023-01341-0

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