Results for lægemiddelovervågningsprocedurer translation from Danish to English

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Danish

lægemiddelovervågningsprocedurer

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Danish

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Danish

det er ligeledes nødvendigt at fastsætte bestemmelser for kontrol med bivirkninger, der opstår ved kliniske forsøg, ved at anvende fællesskabets lægemiddelovervågningsprocedurer for at sikre, at et klinisk forsøg straks bringes til ophør, hvis der er et uacceptabelt højt risikoniveau.

English

it is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials using community surveillance (pharmacovigilance) procedures in order to ensure the immediate cessation of any clinical trial in which there is an unacceptable level of risk.

Last Update: 2017-03-21
Usage Frequency: 3
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Reference: Translated.com

Danish

at sikre et højt niveau for beskyttelse af folkesundheden, bl.a. ved at patienterne hurtigst muligt får adgang til nye og sikre produkter, og ved at der foretages en bedre overvågning af markedet ved hjælp af skærpede kontrol‑ og lægemiddelovervågningsprocedurer

English

to guarantee a high level of public health protection, particularly by providing patients, as swiftly as possible, with innovative and reliable products and by increasing market surveillance by reinforcing monitoring and pharmacovigilance procedures;

Last Update: 2017-04-06
Usage Frequency: 2
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Reference: Translated.com

Danish

for at sikre, at udvalget for risikovurdering inden for lægemiddelovervågning råder over den bedst mulige fagkundskab, og at det fungerer efter hensigten, bør de rapportører, der foretager vurderinger i forbindelse med unionens lægemiddelovervågningsprocedurer, de periodiske, opdaterede sikkerhedsindberetninger, sikkerhedsundersøgelserne efter tilladelse til markedsføring og risikostyringssystemerne, modtage vederlag gennem agenturet.

English

to ensure the highest levels of expertise and the functioning of the pharmacovigilance risk assessment committee, rapporteurs providing assessments for union pharmacovigilance procedures, periodic safety update reports, post-authorisation safety study protocols and risk management systems should receive payment through the agency.

Last Update: 2014-11-21
Usage Frequency: 1
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Reference: Translated.com

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