Traduction de «electronic submission of registration » (Néerlandais → Français) :

Optimisation of the integrated MeSeA system At the time of the FAMHP’s creation, the organisation had just one integrated system, MeSeA, to support its core business, i.e. the electronic submission of registration applications and variations for medicines for human use and the pharmacovigilance applications.
Optimisation of the integrated MeSeA system At the time of the FAMHP’s creation, the organisation had just one integrated system, MeSeA, to support its core business, i.e. the electronic submission of registration applications and variations for medicines for human use and the pharmacovigilance applications.

Op 22/02/2008 werd de 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' gepubliceerd op de EMEA website: [http ...]
Le document 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' a été publié sur le site de l’EMEA le 22/02/2008 : [http ...]

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 aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.
The aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.

d) heeft elke gemachtigd gebruiker die over een elektronische identiteitskaart beschikt toegang tot de toepassingen “Shared Artritis File for Electronic Use (SAFE)”, “Raadpleging van de wilsverklaring inzake euthanasie - eutha-consult”, “ORTHOpedic Prosthesis Identification Data - Electronic Registry - ORTHOpride®”, “Project on cancer of the rectum - Central Image Repository (PROCARE RX)”, “Qermid(c)Pacemakers-Quality Electronic Registration of Medical Implant Devices”, “SMUREG”, “Medico-Administratieve Stromen – Thuisverpleging (MEDADM-INF)”, “ZNA - Zorgportaal – SARAi”, “Registratie van Therapeutische Projecten (TherPro – PatientRegistration)”, “Medega”, “QermidDefibrilateur-Quality Electronic Registration of Medical Implant Devices”, “eHealthBox”, “QermidEndoprothèses-Quality Electronic Registration of Medical Implant Devices”, “QermidPacemakers-Quality Electronic Registration of Medical Implant Devices”, “QermidTuteurs Coronaires- Quality Electronic Registration of Medical Implant Devices”, “Registratiemodule van de Belgische Virtuele Tumorbank”, “Catalogus van de Belgische Virtuele Tumorbank”, “CIVARS – Chapter IV Agreement Requesting System”, “Web Application Metahub”, “Raadpleging van medische kaart”, “TDI - Registratie Module van de “Treatment Demand Indicator””, “eShop - Online bestelling getuigschriften voor verstrekte hulp (Medattest)”, “BNMDR - Belgian NeuroMuscular Disease Registry”, “eHealthConsent”, “Moduledatabank Jeugdhulp Vlaanderen” en “Authentieke bron geneesmiddelen”.
d) chaque utilisateur habilité qui dispose d’une Carte d’Identité Electronique a accès aux applications « Shared Artritis File for Electronic Use (SAFE) », « Consultation de la déclaration anticipée d’euthanasie- eutha-consult », « ORTHOpedic Prosthesis Identification Data - Electronic Registry - ORTHOpride® », « Project on cancer of the rectum - Central Image Repository (PROCARE RX) », « Qermid(c)Pacemakers- Quality Electronic Registration of Medical Implant Devices », « SMUREG », « Flux Medico-Administratifs - Infirmier A Domicile (MEDADM-INF) », « ZNA - Zorgportaal – SARAi », « Enregistrement des projets thérapeutiques (TherPro – PatientRegistration) », « Medega », « QermidDefibrilateur-Quality Electronic Registration of Medical Implant Devices », « eHealthBox », « QermidEndoprothèses- Quality Electronic Registration of Medical Implant Devices », « QermidPacemakers- Quality Electronic Registration of Medical Implant Devices », « QermidTuteurs Coronaires-Quality Electronic Registration of Medical Implant Devices », « Module d’enregistrement de la Tumorothèque Virtuelle Belge », « Catalogue de la Tumorothèque Virtuelle Belge », « CIVARS – Chapter IV Agreement Requesting System », « Web Application Metahub », « Consultation des cartes médicales », « TDI

Qermid©Coronaire stents - Quality oriented Electronic Registration of Medical Implant Devices
Qermid©Défibrillateurs Cardiaques - Quality oriented Electronic Registration of Medical Implant Devices

Qermid©Hartdefibrillatoren - Quality oriented Electronic Registration of Medical Implant Devices | eHealth
Qermid©Défibrillateurs Cardiaques - Quality oriented Electronic Registration of Medical Implant Devices | eHealth

Qermid©Coronaire stents - Quality oriented Electronic Registration of Medical Implant Devices | eHealth
Qermid©Tuteurs coronaires - Quality oriented Electronic Registration of Medical Implant Devices | eHealth

Qermid©Hartdefibrillatoren - Quality oriented Electronic Registration of Medical Implant Devices
Qermid©Pacemakers - Quality oriented Electronic Registration of Medical Implant Devices

Qermid©Endoprothesen - Quality oriented Electronic Registration of Medical Implant Devices
Qermid©Endoprotheses - Quality oriented Electronic Registration of Medical Implant Devices