Vertaling van "validation of applications for clinical trials " (Nederlands → Frans) :

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.

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.
The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.

In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.
In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.

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.

The R&D (research and development) department is required to deal with all relevant applications for clinical trials.
The R&D (research and development) department is required to deal with all relevant applications for clinical trials.

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.

Meestal echter wordt hierbij de Randomized Clinical Trial (RCT) naar voor geschoven als de enig valide onderzoeksvorm (Chambless & Hollon, 1998).
Cependant, la plupart du temps ‘l‘Essai Clinique Randomisé (ECR)’ est présenté comme étant la seule forme de recherche valide (Chambless & Hollon, 1998).