Vertaling van "safety of participants in clinical " (Nederlands → Frans) :

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.

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.

Clinical trials demonstrated the efficacy and safety of FTY720, with participants showing reduced relapses and delayed disease progression.
Des essais cliniques ont démontré l’efficacité et l’innocuité de FTY720 qui provoque une diminution des rechutes et un ralentissement de la progression de la maladie chez les participants.

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.

‐ The Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.
the performance and safety of platelets treated with MIRASOL pathogen reduction technology.

To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.
To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.

The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.
The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.

Moreover, Gilenya has a well-studied safety and tolerability profile that has been characterized in over 2,600 clinical trial patients.
Qui plus est, Gilenya présente un profil d’innocuité et de tolérance très bien étudié chez plus de 2600 malades ayant participé aux essais cliniques.

The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies.
Les discussions de la FDA portent sur la notice du produit et sur la stratégie de la gestion des risques (Risk Evaluation Mitigation Strategy ou REMS) ainsi que sur la mise à jour des données sur son innocuité, mais ne requiert pas plus d’études cliniques.

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.