Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence?

Flynn, Robert; Plueschke, Kelly; Quinten, Chantal; Strassmann, Valerie; Duijnhoven, Ruben G; Gordillo-Marañon, Maria; Rueckbeil, Marcia; Cohet, Catherine; Kurz, Xavier

Flynn, Robert; Plueschke, Kelly; Quinten, Chantal; Strassmann, Valerie; Duijnhoven, Ruben G; Gordillo-Marañon, Maria; Rueckbeil, Marcia; Cohet, Catherine; Kurz, Xavier.

Afiliación

Flynn R; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Plueschke K; Medicines Monitoring Unit, University of Dundee, Dundee, UK.
Quinten C; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Strassmann V; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Duijnhoven RG; Pharmacovigilance Office, Quality and Safety of Medicines, Human Medicines Division European Medicines Agency, Amsterdam, The Netherlands.
Gordillo-Marañon M; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Rueckbeil M; Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Cohet C; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Kurz X; Institute of Cardiovascular Science, Faculty of Population Health, University College London, London, UK.

Clin Pharmacol Ther ; 111(1): 90-97, 2022 01.

Article en En | MEDLINE | ID: mdl-34689339

Asunto(s)

Aprobación de Drogas/métodos; Medicina Basada en la Evidencia/métodos; Agencias Gubernamentales/tendencias; Recolección de Datos; Toma de Decisiones; Europa (Continente); Regulación Gubernamental; Humanos

Texto completo

Imprimir

XML

PubMed Links

Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas / Medicina Basada en la Evidencia / Agencias Gubernamentales Tipo de estudio: Observational_studies / Prognostic_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Clin Pharmacol Ther Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos

Texto completo

Imprimir

XML

PubMed Links

Buscar en Google