Vertaling van "applications for these trials " (Nederlands → Frans) :

Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.
Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.

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 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 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.

- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September
2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA

The extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12).
Cette prolongation est le résultat d’une modification importante de l’utilisation destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.

Extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) study.
Cette prolongation est le résultat d’une modification importante de la demande destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.