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Vertaling van "famhp for evaluation " (Nederlands → Frans) :

Considerable attention was focused in 2007 on increased cooperation on the part of the FAMHP with the ethics committees, with the following results: ●● An interactive website with a web application that makes possible the “simple” management of communication actions between the different ethics committees, the FAMHP, the sponsors and researchers, and also monitors the different stages in the evaluation of each application by the ethics committees ●● Systematic consultation for the more complex scientific applications ●● Further optimi ...[+++]

Considerable attention was focused in 2007 on increased cooperation on the part of the FAMHP with the ethics committees, with the following results: ●● An interactive website with a web application that makes possible the “simple” management of communication actions between the different ethics committees, the FAMHP, the sponsors and researchers, and also monitors the different stages in the evaluation of each application by the ethics committees ●● Systematic consultation for the more complex scientific applications ●● Further optimi ...[+++]


This agreement provides for an enhanced collaboration between the two institutions in the evaluation of quality data in applications for MA or associated amendments (variations) for vaccines for veterinary use, “Good Manufacturing Practices” inspection (GMP) and post-marketing reviews (monitoring by the FAMHP on samples taken).

This agreement provides for an enhanced collaboration between the two institutions in the evaluation of quality data in applications for MA or associated amendments (variations) for vaccines for veterinary use, “Good Manufacturing Practices” inspection (GMP) and post-marketing reviews (monitoring by the FAMHP on samples taken).


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 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 FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.


The FAMHP is concerned with the evaluation of preclinical and quality aspects of a trial.

The FAMHP is concerned with the evaluation of preclinical and quality aspects of a trial.




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Date index: 2024-10-04
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