Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

IntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuous evaluation of the benefit–risk balance of a medicinal product in the post-authorisation phase. The PSUR submission frequency for authorised active substances and combinations of active substances a...

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Main Authors: María Gordillo-Marañón, Gianmario Candore, Marta López-Fauqued, Katerina-Christina Deli, Loris Piccolo, Paolo Alcini, Tom Paternoster-Howe, Irene Rager, Robin Ruepp, Menno van der Elst
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-02-01
Series:Frontiers in Medicine
Subjects:
pharmacovigilance
drug safety
periodic safety update report
EURD list
data driven
prediction
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2024.1299190/full

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