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

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 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.

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.

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:

In December 2009, Tasigna was submitted for US and European regulatory approvals for first-line use in CML after new data from the global ENESTnd trial, the largest head-to-head comparison of a targeted therapy against Glivec ever conducted, showed Tasigna produced faster and deeper responses than Glivec in newly diagnosed CML patients.
Des demandes d’autorisations pour Tasigna ont été déposées en décembre 2009 aux Etats-Unis et dans l’Union européenne en tant que traitement de première intention de la LMC. De nouveaux résultats de l’essai ENESTnd réalisé à l’échelle mondiale, la plus vaste confrontation jamais entreprise entre un traitement ciblé et Glivec, ont montré que Tasigna provoquait des réponses plus rapides et plus profondes que Glivec chez les malades souffrant d'une LMC diagnostiquée récemment.

Menveo, which was submitted in 2008 for US regulatory approval as a new vaccine to protect against four common types of meningococcal meningitis in people age 11-55, has received a Complete Response letter from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.
Menveo, a été soumis en 2008 aux autorités sanitaires américaines en vue d’obtenir son autorisation en tant que vaccin contre quatre types communs de méningite à méningocoques chez les personnes âgées de 11 à 55 ans. Ce médicament a reçu de la FDA une «Complete Response letter» demandant des informations complémentaires sur les sections Clinique et CMC (Chemistry Manufacturing and Control) du dossier.

2007 also saw the launch of the new methodology for detecting and evaluating serious adverse effects, and it is now vital to put this into practice as soon as possible.
2007 also saw the launch of the new methodology for detecting and evaluating serious adverse effects, and it is now vital to put this into practice as soon as possible.

Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures — Minneapolis- St. Paul, New York City, and San Francisco, 1993-1995 MMWR 1997; 46:21-8.
Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures — Minneapolis- St. Paul, New York City, and San Francisco, 1993-1995 MMWR 1997 ; 46:21-8.

The “PRE pillar” is also responsible for the evaluation of the quality, safety and efficacy of the end products.
The “PRE pillar” is also responsible for the evaluation of the quality, safety and efficacy of the end products.

An individualised and more detailed file to be sent to individuals reporting events in response to each report; this file contains a summary of the evaluation of the report by the BCGH-CBPH working group and the documentation that has served as the basis for this.
An individualised and more detailed file to be sent to individuals reporting events in response to each report; this file contains a summary of the evaluation of the report by the BCGH-CBPH working group and the documentation that has served as the basis for this.