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Traduction de «responsible for the evaluation » (Néerlandais → Français) :

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.


The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.


The “PRE pillar” is also responsible for the evaluation of the quality, safety and efficacy of the end products.

The “PRE pillar” is also responsible for the evaluation of the quality, safety and efficacy of the end products.


An individualised and more detailed file to be sent to individuals reporting events in response to each report; this file contains a summary of the evaluation of the report by the BCGH-CBPH working group and the documentation that has served as the basis for this.

An individualised and more detailed file to be sent to individuals reporting events in response to each report; this file contains a summary of the evaluation of the report by the BCGH-CBPH working group and the documentation that has served as the basis for this.


The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.


Progressievrije overleving, gedocumenteerd met gebruik van RECIST (Response Evaluation Criteria in Solid Tumours) en beoordeeld via een geblindeerde, onafhankelijke centrale beoordeling, was het primaire eindpunt.

Le critère principal était la survie sans progression, documentée selon les critères RECIST (Response Evaluation Criteria in Solid Tumors)) et évaluée en aveugle par un comité d’évaluation centralisé indépendant.


Het primaire eindpunt voor de studie was PFS, geëvalueerd door RECIST (Response Evaluation Criteria in Solid Tumors).

Le critère principal d'évaluation de l'étude était la SSP évaluée au moyen des critères RECIST (Response Evaluation Criteria in Solid Tumors).


Het primaire eindpunt voor de studie was de progressievrije overleving (PFS) beoordeeld volgens RECIST (Response Evaluation Criteria in Solid Tumors), gebaseerd op het oordeel van de onderzoeker (lokale radiologie).

Le critère principal d'évaluation de l'étude était la survie sans progression (SSP) évaluée selon les critères RECIST (Response Evaluation Criteria in Solid Tumors), sur la base de l'évaluation de l'investigateur (radiologie locale).


Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission


Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for h ...[+++]

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for h ...[+++]




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Date index: 2021-04-23
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