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Clinical trials will start in July for this vaccine.

Vertaling van "clinical trials whenever this involves " (Nederlands → Frans) :

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.


" 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


Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.

Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.


The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.


If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.

If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.


The publication of a guideline on “Exploratory Clinical Trials” and the various guest speaker presentations at various international fora have definitely contributed to this.

The publication of a guideline on “Exploratory Clinical Trials” and the various guest speaker presentations at various international fora have definitely contributed to this.


Two potential regulatory submissions are planned for 2010 based on the outcome of clinical trials of this medicine in patients with neuroendocrine tumors (NET) as well as tuberous sclerosis complex (TSC).

Deux demandes d’autorisation sont susceptibles d’être déposées en 2010 sur la base des résultats des essais cliniques de ce médicament sur des malades atteints d’une tumeur neuroendocrine (TNE) et d’une sclérose tubéreuse complexe (STC).


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.


Clinical trials will start in July for this vaccine.

Les essais cliniques de ce vaccin débuteront en juillet.


Novartis ranks as having one of the industry’s most competitive pharmaceuticals development pipelines with 147 projects in clinical development, of which 27 involve new molecular entities in late-stage trials or under regulatory review.

Novartis est considéré comme possédant l’un des pipelines de produits pharmaceutiques les plus concurrentiels de l’industrie avec 147 projets en développement clinique, dont 27 impliquent de nouvelles entités moléculaires qui sont en phase ultime d’essais ou en cours d’examen par les autorités réglementaires.




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Date index: 2022-01-30
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