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Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns

INTRODUCTION: The European Risk Management Plan (EU-RMP) is a proactive planning tool for identification, characterisation and management of important risks and missing information throughout the lifecycle of a medicinal product. Over the past 15 years the EU-RMP has been a part of the pharmacovigil...

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Detalles Bibliográficos
Autores principales: Holm, Julia Elvira Johanna, Ruppert, Jan Gustav, Ramsden, Samuel David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8817998/
https://www.ncbi.nlm.nih.gov/pubmed/35099785
http://dx.doi.org/10.1007/s40290-021-00414-8