Vertaling van "guideline on data requirements " (Nederlands → Frans) :

Daarnaast werkte het Agentschap mee aan de ontwikkeling van een richtlijn over vaccins tegen mond- en klauwzeer: Draft reflection paper on data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza en Guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza, Blue Tongue and Foot and Mouth Disease.
L’Agence collabore également au développement d’une directive relative aux vaccins contre la fièvre aphteuse : Draft reflection paper on data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza en Guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza, Blue Tongue and Foot and Mouth Disease.

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.

Mdeon follows the guidelines authorised in connection with its recognition and ensures strict compliance with the legal requirements (article 10 of the law of 25 March 1964 on medicines).
Mdeon follows the guidelines authorised in connection with its recognition and ensures strict compliance with the legal requirements (article 10 of the law of 25 March 1964 on medicines).

Speerpunt VACCINS voor diergeneeskundig gebruik. In 2010 was er een actieve deelname van het FAGG aan de werkgroep voor de evaluatie van immunologische producten en aan het CVMP in de ontwikkeling van drie belangrijke documenten met betrekking tot vaccins voor diergeneeskundig gebruik: -- Draft reflection paper on data requirements
Domaine d’excellence VACCINS à usage vétérinaire. En 2010, l’AFMPS a également activement collaboré au groupe de travail pour l’évaluation de produits immunologiques ainsi qu’au CVMP lors du développement de trois documents importants relatifs aux vaccins à usage vétérinaire : -- Draft reflection paper on data requirements

haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.
haemovigilance data and monitoring their implementation ●● The first annual report of the Haemovigilance Centre was published in 2007 Since November 2005, hospitals and blood establishments have been required to report to the Belgian Centre for Haemovigilance of the FAMHP serious reactions during the collection or administration of blood components and serious events relating to the quality or safety of blood components.

These data formed the basis of a recent US National Comprehensive Cancer Network (NCCN) update on treatment guidelines for neuroendocrine tumors.
Ces résultats sont à la base d’une mise à jour récente des directives de traitement des tumeurs neuroendocrines par le National Comprehensive Cancer Network (NCCN) aux Etats- Unis.

-- Further guidance on interpretation of the data from guideline CVMP-VICH GL27 guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)
-- Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)

Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and bupropion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.
Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and Buproprion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.

These data formed the basis of the recent US National Comprehensive Cancer Network (NCCN) update on treatment guidelines for neuroendocrine tumors.
Ces résultats sont à la base de la mise à jour récente des directives de traitement des tumeurs neuroendocrines par le National Comprehensive Cancer Network (NCCN) aux Etats-Unis.

The application was withdrawn following the Committee for Medicinal Products for Human Use (CHMP) request to provide additional data satisfying the relevant EU guidelines.
Cette décision est survenue à la suite de la demande du CHMP (Comité européen pour les produits médicaux à usage humain) de fournir des données supplémentaires afin de satisfaire aux directives de l'UE.