Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Loris Piccolo"'
Autor:
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
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
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 activ
Externí odkaz:
https://doaj.org/article/0a377b317bc14f79a773c8fe17459be0
Autor:
Gianmario Candore, Sebastian Monzon, Jim Slattery, Loris Piccolo, Rodrigo Postigo, Xavier Xurz, Sabine Strauss, Peter Arlett
Publikováno v:
Drug Safety
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 rep
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8c1360220cc58f2c921eda7ecf798f56
https://doi.org/10.1007/s40264-021-01137-0
https://doi.org/10.1007/s40264-021-01137-0
Autor:
Julie Durand, Jean‐Michel Dogné, Catherine Cohet, Kate Browne, María Gordillo‐Marañón, Loris Piccolo, Cosimo Zaccaria, Georgy Genov
Publikováno v:
Clinical pharmacology and therapeutics.
Prior to deployment of COVID-19 vaccines in the European Union (EU) in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports and real-world evidence, was anticipated. The European Medicines Agency (EMA
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1fca05a13e47e3ab840e68a9de24454b
https://pubmed.ncbi.nlm.nih.gov/36524423
https://pubmed.ncbi.nlm.nih.gov/36524423