6ER-030 Clinical investigations of medical devices: an example from a local ethical committee

BACKGROUND: According to the National Legal Framework (D. Lgs 507/92; D. Lgs 46/97), medical devices (MDs), as well as medications, must undergo clinical investigations following strict rules concerning context, ethics, objectives and methods that must be approved by local ethical committees (ECs)....

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Detalhes bibliográficos
Publicado no:Eur J Hosp Pharm
Main Authors: Inserra, C, Lonati, G, Zovi, A, Zampogna, L, Scalzi, V, Zerega, G, Piacenza, M, Minghetti, P
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Group 2018
Assuntos:
Section 6: Education and research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7535155/
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/ejhpharm-2018-eahpconf.522
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