Usted buscó: standard operating procedures (sop) (Danés - Italiano)

hver inspektør modtager et dokument med instruktioner (standard operating procedures) og detaljerede oplysninger om opgaver, ansvarsområder og løbende krav til uddannelse.
ogni ispettore riceve un documento contenente le procedure operative normali e i particolari relativi ai compiti, alle responsabilità e agli obblighi in materia di formazione continua.

standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders

standard operating procedure on referrals in accordance with the provisions of council directive 75/ 319/ eec in the case of safety concerns related to medicinal products marketed in the european union
standard operating procedure on referrals in accordance with the provisions of council directive 75/ 319/ eec in the case of safety concerns related to medicinal products marketed in the european union

need for post- marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
need for post-marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure

- forsøgsprotokol inklusive begrundelsen tor undersøgelsens gennemføralse, formål, statistisk design og metodologi og tillige de vilkår, hvorunder undersøgelsen gennemføres og styres, samt oplysninger om det anvendte undersøgelsesprodukt, referencelægemiddel og/eller placebo - standardprocedurer for håndtering af kliniske afprøvninger "standard operating procedures")
­ il protocollo, la motivazione, gli obiettivi e il modello statistico, nonché la metodologia di esecuzione della prova, le condizioni in cui essa è stata eseguita unitamente ad indicazioni particolareggiate in merito al prodotto oggetto di prova, al medicinale di riferimento e/o al placebo utilizzati;