Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model.
Br J Clin Pharmacol
; 86(12): 2530-2534, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-31426120
ABSTRACT
Regulatory science underpins the objective evaluation of medicinal products. It is therefore imperative that regulatory science and expertise remain at the cutting edge so that innovations of ever-increasing complexity are translated safely and swiftly into effective, high-quality therapies. We undertook a comprehensive examination of the evolution of science and technology impacting on medicinal product evaluation over the next 5-10 years and this horizon-scanning activity was complemented by extensive stakeholder interviews, resulting in a number of significant recommendations. Highlighted in particular was the need for expertise and regulatory science research to fill knowledge gaps in both more fundamental, longer-term research, with respect to technological and product-specific challenges. A model is proposed to realise these objectives in Europe, comprising a synergistic relationship between the European Medicines Agency, the European Medicines Regulatory Network and academic research centres to establish a novel regulatory science and innovation platform.
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1
Base de dados:
MEDLINE
Assunto principal:
Conhecimento
/
Controle de Medicamentos e Entorpecentes
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article