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Eerste hindernis
First-pass

Traduction de «first phase » (Néerlandais → Français) :

TERMINOLOGIE
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TRADUCTIONS EN CONTEXTE
The first phase in the implementation of a helpdesk in this area has been elaborated and received positive validation from the sector, so that further development work can take place in the course of 2008.

The first phase in the implementation of a helpdesk in this area has been elaborated and received positive validation from the sector, so that further development work can take place in the course of 2008.


Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.

Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.


Transition and backlog In the first phase of the transition to a new structure for the FAMHP, the emphasis is on the reorganisation and restructuring of the Registration (marketing authorisation) department.

Transition and backlog In the first phase of the transition to a new structure for the FAMHP, the emphasis is on the reorganisation and restructuring of the Registration (marketing authorisation) department.


The year 2008 was the first phase in the transformation or switch to a new structure. The 3 committees of the FAMHP have been created and the selection procedure for the 3 Directors-General initiated.

The year 2008 was the first phase in the transformation or switch to a new structure. The 3 committees of the FAMHP have been created and the selection procedure for the 3 Directors-General initiated.


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In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.

In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.


o Significant innovation momentum underpinned by FDA approval of Gilenya as first-inclass novel therapy for relapsing multiple sclerosis; Tasigna received positive CHMP opinion and approval in Switzerland as first-line therapy; positive Phase III trial data for Onbrez over salmeterol and positive Phase III data for MenB

o Accélération importante de l’innovation, soutenue par l’homologation par la FDA de Gilenya, un nouveau traitement, premier de sa classe, contre la sclérose en plaques cyclique; Tasigna a obtenu un préavis favorable du CHMP et a été autorisé en Suisse comme traitement de première ligne; résultats positifs d’un essai de phase III pour Onbrez comparé à salmétérol et bons résultats de phase III pour MenB


ASA404 Non-small cell lung cancer (NSCLC) 2012 III - First-line Phase III NSCLC trial stopped in March 2010, secondline Phase III NSCLC trial ongoing (interim analysis in H2 2010)

DEB025 Hépatite C ≥ 2014 II - Sous licence de Debiopharm au T1 2010 EPO906 Cancer ovarien 2010 III - En voie d’être soumis en 2010 Exjade Thalassémie nontransfusion dépendante 2011 II


Top line Phase III results (Study 2301) from SMC021 in osteoarthritis did not meet the first of three co-primary endpoints.

Les résultats expérimentaux de phase III de SMC021 (étude 2301) dans l’ostéoarthrite montrent que le premier des trois critères principaux conjoints n’a pas été satisfait.


SOM230 became the first medical therapy to show efficacy in treating Cushing's disease in a Phase III trial.

SOM230 est devenu le premier traitement médical à avoir montré son efficacité dans la maladie de Cushing lors d’un essai de phase III. La maladie de Cushing est une perturbation invalidante du système endocrinien pour laquelle il n’existe actuellement aucun médicament autorisé.


With a view to the further optimisation of the working processes, structure and deployment of available resources, the FAMPS’s structure was redesigned during the first main phase of the transition.

With a view to the further optimisation of the working processes, structure and deployment of available resources, the FAMPS’s structure was redesigned during the first main phase of the transition.




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Date index: 2021-10-14
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