Cargando…
Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs
INTRODUCTION: Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products an...
Autores principales: | Mazzaglia, Giampiero, Straus, Sabine M. J., Arlett, Peter, da Silva, Daniela, Janssen, Heidi, Raine, June, Alteri, Enrica |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808048/ https://www.ncbi.nlm.nih.gov/pubmed/29124666 http://dx.doi.org/10.1007/s40264-017-0604-4 |
Ejemplares similares
-
Improving the Safety of Medicines in the European Union: From Signals to Action
por: Potts, Joanne, et al.
Publicado: (2019) -
The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
por: Cavaleri, Marco, et al.
Publicado: (2021) -
Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
por: Santoro, Aniello, et al.
Publicado: (2017) -
The European Medicines Agency's approval of new medicines for type 2 diabetes
por: Blind, Eberhard, et al.
Publicado: (2018) -
Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review
por: Paludan-Müller, Asger S., et al.
Publicado: (2021)