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Traduction de «safety of participants in clinical trials » (Néerlandais → Français) :

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.


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.


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.


" Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.‰

ÿ Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the princinciples that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Ÿ


‐ 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.


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.


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.


In zijn vergadering van 11 december 2010 besprak de Nationale Raad uw vraag van 19 mei 2010 betreffende de overdracht van materiaal afkomstig van biopsieën naar het buitenland : " Is it allowed for hospitals - the anatomo-pathological services - to send biopsy blocks of patients participating in a clinical trial and signing an informed consent, to a central laboratory outside Belgium ; e.g.

En sa séance du 11 décembre 2010, le Conseil national a examiné votre question du 19 mai 2010 concernant la transmission de prélèvements biopsiques à l'étranger : « Is it allowed for hospitals - the anatomo-pathological services - to send biopsy blocks of patients participating in a clinical trial and signing an informed consent, to a central laboratory outside Belgium ; e.g.




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Date index: 2024-05-22
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