An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach

BACKGROUND: Legislative requirements for Marketing Authorisation Holders (MAHs) to maintain a Pharmacovigilance System Master File (PSMF) were introduced in the European Union (EU) in 2010, operationalised in 2012 and subsequently introduced in other territories. There are no internationally agreed...

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Detalles Bibliográficos
Autores principales: Lavery, Clare, Emmott, Joanne, Jeck-Thole, Sabine, Rouben, Pascale, Usher, Dionne, van der Spuij, Willemijn, Woodward, Louise
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9334448/
https://www.ncbi.nlm.nih.gov/pubmed/35723862
http://dx.doi.org/10.1007/s40290-022-00422-2

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9334448/
https://www.ncbi.nlm.nih.gov/pubmed/35723862
http://dx.doi.org/10.1007/s40290-022-00422-2

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