Vertaling van "well as first submissions " (Nederlands → Frans) :

Many development projects are progressing toward regulatory submissions in 2010, with up to five in oncology: two additional indications for Afinitor as well as first submissions for the development projects SOM230 (Cushing's disease), LBH589 (Hodgkin's lymphoma) and EPO906 (ovarian cancer).
Des demandes d’autorisation pour de nombreux projets en développement sont en voie d’être déposées en 2010, dont jusqu'à cinq en oncologie : deux indications supplémentaires pour Afinitor ainsi que les projets en développement SOM230 (maladie de Cushing), LBH589 (lymphome de Hodgkin) et EPO906 (cancer des ovaires).

Others include the first submission in Europe for MenB, which has the potential to become the first global vaccine against the B serogroup of meningococcal meningitis.
D’autres demandes comprennent la première soumission en Europe pour MenB qui est susceptible de devenir le premier vaccin au monde contre le sérogroupe B de la méningite à méningocoque.

The first submission was made for ages 11-55.
La demande initiale d’enregistrement porte sur les classes d’âge de 11 à 55 ans.

The first submissions were previously planned for 2009, but were accelerated to December 2008 after data from two clinical studies showed adults and children achieved rapid and long-lasting clinical remission of symptoms of these diseases.
Prévues initialement en 2009, les premières demandes d’autorisation ont été avancées à décembre 2008, après que des résultats de deux études cliniques ont montré que les adultes et les enfants obtenaient rapidement des rémissions cliniques de longue durée des symptômes de ces maladies.

Submission for EU approval of a triple-medicine combination therapy for hypertension in a single pill containing Tekturna/Rasilez, amlodipine and hydrochlorothiazide was achieved in May, following the US submission in the first quarter.
l’hypertension en un comprimé unique associant Rasilez/Tekturna, amlodipine et hydrochlorothiazide, dans la foulée d’un dépôt similaire au premier trimestre aux Etats-Unis.

Other important regulatory approvals in 2009 were received for the H1N1 pandemic flu vaccines in the US and Europe as well as the first-ever biosimilar in Japan and Prevacid 24HR, the first and only OTC version of this proton pump inhibitor in the US.
D’autres homologations importantes ont été reçues en 2009 pour les vaccins contre la pandémie de grippe H1N1 aux Etats-Unis et en Europe ainsi que pour le premier biosimilaire jamais produit au Japon et Prevacid 24HR, la première et unique version en vente libre de cet inhibiteur de la pompe à protons, aux Etats-Unis.

Cash flow Cash flow from operating activities from continuing operations rose 29% to USD 4.6 billion in the first half of 2009 compared to the year-ago period as a result of improved working capital management as well as lower financial and tax payments in the first six months of 2009 compared to the prior-year period.
Flux de trésorerie Au premier semestre 2009, les flux de trésorerie provenant des activités opérationnelles liées aux activités poursuivies ont progressé à USD 4,6 milliards, en hausse de 29% par rapport au premier semestre 2008. Cette progression résulte d’une amélioration de la gestion des fonds de roulement ainsi que d’une baisse des paiements financiers et fiscaux au premier semestre 2009, par rapport à la période correspondante de 2008.

Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s
Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s

The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.
The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.

The first thing to do is to break the law of silence and have the courage to tackle the taboo on suicide as well as the many prejudices around it.
Il s’agit avant tout de rompre la loi du silence, d’oser affronter le tabou lié au suicide, d’aborder les multiples préjugés qui l’entourent.