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- standardprocedurer for håndtering af kliniske afprøvninger (»standard operating procedures«)
os processos dos doentes e outros dados originais devem ser conservados durante tanto tempo quanto o hospital, instituição ou consultório o permitam; c)
Last Update: 2014-02-06
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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
Last Update: 2011-10-23
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hver inspektør modtager et dokument med instruktioner (standard operating procedures) og detaljerede oplysninger om opgaver, ansvarsområder og løbende krav til uddannelse.
deve ser fornecido a cada inspector um documento que estabeleça procedimentos operativos normalizados com pormenores quanto às obrigações, às responsabilidades e aos requisitos permanentes de formação.
Last Update: 2014-10-23
Usage Frequency: 1
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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
Last Update: 2011-10-23
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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
Last Update: 2011-10-23
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5. hver inspektør modtager et dokument med instruktioner (standard operating procedures) og detaljerede oplysninger om opgaver, ansvarsområder og løbende krav til uddannelse. disse instruktioner holdes ajour.
5. deve ser fornecido a cada inspector um documento que estabeleça procedimentos operativos normalizados com pormenores quanto às obrigações, às responsabilidades e aos requisitos permanentes de formação. estes procedimentos serão mantidos actualizados.
Last Update: 2008-03-04
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- 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")
- o protocolo, incluindo a fundamentação, objectivos e a concepção estatística e a metodologia do ensaio, as condições ao abrigo das quais este se processa e é gerido, bem como informações sobre o produto experimental, o medicamento de referência e/ou o placebo utilizados,
Last Update: 2014-02-06
Usage Frequency: 1
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