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Vertaling van "protect the participants in clinical " (Nederlands → Frans) :

It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.

It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.


The safety of participants in clinical trials with investigational products (IMP) and of the users of the authorised medicines and health products is of fundamental importance.

The safety of participants in clinical trials with investigational products (IMP) and of the users of the authorised medicines and health products is of fundamental importance.


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.


Its clinical manifestations are looked upon as the final result of a negative spiral that sets in if the risk factors can no longer be counterbalanced by the protective factors that each individual possesses to a certain extent.

Ce qui se présente de façon clinique est considéré comme le résultat final d’une spirale négative qui s’installe si les facteurs de risque ne peuvent plus être contrebalancés par les facteurs de protection dont chacun dispose dans une certaine mesure.


Vaccines and Diagnostics Menveo, a novel vaccine in clinical development to protect against four common types of meningococcal meningitis, is making good progress toward US and European regulatory approvals for initial use in adolescents (from age 11) and adults.

Vaccins et Diagnostic Menveo, un nouveau vaccin en développement clinique contre quatre types communs de méningite à méningocoques progresse vers l’obtention d’autorisations aux Etats-Unis et en Europe pour une première utilisation chez les adolescents (à partir de l’âge de 11) et les adultes.


Tekturna/Rasilez (USD 119 million, +117% lc), the first new type of high blood pressure medicine in more than a decade, has accelerated its growth pace thanks to an increasing body of data affirming its ability to reduce blood pressure for more than 24 hours, its potential benefits for organ protection, and its consistent superiority in clinical trials over ramipril, a leading ACE inhibitor (another class of high blood pressure medicines).

Rasilez/Tekturna (USD 119 millions, +117% en m. l.), premier médicament d’un nouveau type contre l’hypertension depuis plus d’une décennie, a enregistré une accélération de sa croissance grâce à une masse grandissante de données faisant état de sa capacité à réduire la pression sanguine pendant plus de 24 heures, de ses bénéfices potentiels dans la protection des organes et de sa supériorité constante, manifestée lors des essais cliniques, sur le ramipril, un inhibiteur de l’IEC (une autre classe de médicaments hypotenseurs).


Clinical trials are underway in other age groups, including as young as from two months, to protect against the serogroups A, C, W-135 and Y found with this often-fatal bacterial infection.

Des essais cliniques sont en cours dans d’autres tranches d’âges, dès l’âge de deux mois, pour les protéger contre les sérogroupes A, C, W-135 et Y que l’on trouve dans cette maladie bactérienne souvent mortelle.


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.


16. UZ Leuven : The participation of the clinical pharmacist in detecting drug-related admissions (PDF)

15. Cliniques de l'Europe, Bruxelles : Gestion des médicaments à haut risque : projets d’amélioration (PDF)


In 2005, we participated in an industry-wide effort to improve transparency by creating an online portal, disclosing results from more than 250 000 clinical trials conducted worldwide.

En 2005, nous avons participé à une opération conjointe de tous les acteurs de notre branche en vue d’améliorer la transparence sur les essais cliniques. Un portail Internet a été créé, recensant les résultats de plus de 250’000 essais cliniques conduits à travers le monde.




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Date index: 2021-09-13
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