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Vertaling van "famhp is responsible for evaluating new applications " (Nederlands → Frans) :

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the 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’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 R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.


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 ...[+++]

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 ...[+++]


Furthermore an expert committee, the Committee for Advanced Therapies (CAT), was A transversal working group has been established within the FAMHP which is responsible for the coordination of this matter and the introduction of the new regulations in practice. This consultation process arrived at the following decisions:

Furthermore an expert committee, the Committee for Advanced Therapies (CAT), was A transversal working group has been established within the FAMHP which is responsible for the coordination of this matter and the introduction of the new regulations in practice. This consultation process arrived at the following decisions:


Finally, the implementation of the new structure of the FAMHP will have a considerable impact on the Veterinary Medicines unit, as the current powers/responsibilities relating to the PRE and POST pillars will be redistributed.

Finally, the implementation of the new structure of the FAMHP will have a considerable impact on the Veterinary Medicines unit, as the current powers/responsibilities relating to the PRE and POST pillars will be redistributed.


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.




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Date index: 2021-12-15
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