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

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 ...]

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.

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.

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