Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe.

Jonker, Carla J; Bakker, Elisabeth; Kurz, Xavier; Plueschke, Kelly

Jonker, Carla J; Bakker, Elisabeth; Kurz, Xavier; Plueschke, Kelly.

Afiliação

Jonker CJ; European Medicines Agency (EMA), Amsterdam, Netherlands.
Bakker E; Dutch Medicines Evaluation Board (CBG-MEB), Utrecht, Netherlands.
Kurz X; European Medicines Agency (EMA), Amsterdam, Netherlands.
Plueschke K; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), Groningen, Netherlands.

Front Pharmacol ; 13: 924648, 2022.

Article em En | MEDLINE | ID: mdl-35991868

Palavras-chave

guideline on registry-based studies; orphan designation; orphan medicinal product (OMP); patient registry; real-world evidence (RWE)

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline / Prognostic_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline / Prognostic_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article