Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap.
Drug Discov Today
; 26(2): 283-288, 2021 02.
Article
em En
| MEDLINE
| ID: mdl-33127567
ABSTRACT
Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.
Texto completo:
1
Eixos temáticos:
Inovacao_tecnologica
Base de dados:
MEDLINE
Assunto principal:
Difusão de Inovações
/
Pesquisa Translacional Biomédica
Tipo de estudo:
Prognostic_studies
/
Sysrev_observational_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article