Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience

INTRODUCTION: In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing authorization. A comprehensive revision of the EU Guide...

Descripción completa

Detalles Bibliográficos
Autores principales: Esslinger, Suzan, Quinn, Linda, Sampat, Sami, Otero-Lobato, Marijo, Noël, Wim, Geldhof, Anja, Herijgers, Nicole, Reeder, Sarah-Jane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069847/
https://www.ncbi.nlm.nih.gov/pubmed/35509028
http://dx.doi.org/10.1186/s40780-022-00244-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069847/
https://www.ncbi.nlm.nih.gov/pubmed/35509028
http://dx.doi.org/10.1186/s40780-022-00244-z

Ejemplares similares