Vertaling van "ctfg agreements have been made " (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.

Average Wholesale Price litigation Claims have been brought against various pharmaceutical companies, including NPC and certain Sandoz entities, alleging that they fraudulently overstated the Average Wholesale Price and “best price”, which are, or have been, used by the US federal and state governments in the calculation of, respectively, Medicare reimbursements and Medicaid rebates. In some cases, motions to dismiss or (cross-) motions for summary judgment in other cases have been made and are currently pending.
Litige concernant le prix de gros moyen Des plaintes ont été déposées contre différentes sociétés pharmaceutiques, dont NPC et certaines entités de Sandoz, au motif que celles-ci auraient frauduleusement exagéré le prix de gros moyen (average wholesale price [AWP]) et le «meilleur prix» qui sont ou ont été utilisés par le gouvernement fédéral américain et des gouvernements d’Etat pour calculer les remboursements des médicaments dans le cadre du programme Medicare et les rabais dans celui de Medicaid.

Average Wholesale Price litigation Claims have been brought against various pharmaceutical companies, including NPC and certain Sandoz entities, alleging that they fraudulently overstated the Average Wholesale Price and “best price”, which are, or have been, used by the US federal and state governments in the calculation of, respectively, Medicare reimbursements and Medicaid rebates. In some cases, motions to dismiss or (cross-) motions for summary judgment have been made and are currently pending.
Litige concernant le prix de gros moyen Des plaintes ont été déposées contre différentes sociétés pharmaceutiques, dont NPC et certaines entités de Sandoz, au motif que celles-ci auraient frauduleusement exagéré le prix de gros moyen (average wholesale price [AWP]) et le «meilleur prix» qui sont ou ont été utilisés par le gouvernement fédéral américain et des gouvernements d’Etat pour calculer les remboursements des médicaments dans le cadre du programme Medicare et les rabais dans celui de Medicaid.

Contacts have been made with the federal police’s stress counsellors and several ways of co-operating have been assessed.
Des contacts ont été établis avec l’équipe « stress » de la police fédérale et plusieurs possibilités de collaboration ont été évaluées.

The recommendations made in this report are based on the available epidemiological data, the main observations that have been made with regard to the problem and an inventory of the actions already put in place in Belgium.
Les recommandations émises découlent des données épidémiologiques disponibles, des principaux constats établis par rapport au problème et d’un inventaire d’actions déjà mises en place en Belgique.

No major ultrasound 17 technical advances have been made in order to reduce the inter-observer variability of the technique strictly linked to opertaor's experience.
No major ultrasound 34 technical advances have been made in order to reduce the inter-observer variability of the technique strictly linked to opertaor's experience.

On the basis of these results, a series of suggestions for improvement have been made, initiatives for collaboration worked out and training offered to the health professionals from these Centra.
Sur base des résultats de cette enquête, des pistes d’améliorations sont proposées, des initiatives de collaboration sont élaborées et des formations sont offertes aux intervenants de ces Centra.

This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.

NPC has been cooperating with parallel civil and criminal investigations by the EDPA into allegations of potential off-label marketing and promotion of the epilepsy therapy Trileptal as well as certain payments made to healthcare providers in connection with this medicine. Earlier this year, NPC entered into a plea agreement with the EDPA, which is contingent on court approval, to resolve criminal allegations.
NPC coopère aux investigations civiles et criminelles que l’EDPA mène en parallèle au sujet d’accusations de promotion de Trileptal, un traitement contre l’épilepsie, pour des indications pour lesquelles ce produit n’a pas été autorisé, et de certains paiements à des prestataires de soins de santé en lien avec ce médicament.

De termen en voorwaarden opgenomen in het register op de website van de Europese Commissie vermelden “health claims should only be made for the nutrient, substance, food or food category for which they have been authorised, and not for the food product that contains them”.
Les termes et conditions repris sur le registre du site de la Commission européenne mentionnent que “health claims should only be made for the nutrient, substance, food or food category for which they have been authorised, and not for the food product that contains them”.