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Traduction de «trials in belgium » (Néerlandais → Français) :

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.


However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.

However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.


The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.


Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.

Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.


In zijn vergadering van 11 december 2010 besprak de Nationale Raad uw vraag van 19 mei 2010 betreffende de overdracht van materiaal afkomstig van biopsieën naar het buitenland : " Is it allowed for hospitals - the anatomo-pathological services - to send biopsy blocks of patients participating in a clinical trial and signing an informed consent, to a central laboratory outside Belgium ; e.g.

En sa séance du 11 décembre 2010, le Conseil national a examiné votre question du 19 mai 2010 concernant la transmission de prélèvements biopsiques à l'étranger : « Is it allowed for hospitals - the anatomo-pathological services - to send biopsy blocks of patients participating in a clinical trial and signing an informed consent, to a central laboratory outside Belgium ; e.g.


The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.

The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.




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Date index: 2024-05-18
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