Traduction de «famhp is responsible for evaluating » (Néerlandais → Français) :

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 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.

If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.
If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.

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.

In 2007 the Legal service of the FAMHP was responsible for: ●● Legislation
In 2007 the Legal service of the FAMHP was responsible for: ●● Legislation

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.

Considerable attention was focused in 2007 on increased cooperation on the part of the FAMHP with the ethics committees, with the following results: ●● An interactive website with a web application that makes possible the “simple” management of communication actions between the different ethics committees, the FAMHP, the sponsors and researchers, and also monitors the different stages in the evaluation of each application by the ethics committees ●● Systematic consultation for the more complex scientific applications ●● Further optimisation of the functioning of
Considerable attention was focused in 2007 on increased cooperation on the part of the FAMHP with the ethics committees, with the following results: ●● An interactive website with a web application that makes possible the “simple” management of communication actions between the different ethics committees, the FAMHP, the sponsors and researchers, and also monitors the different stages in the evaluation of each application by the ethics committees ●● Systematic consultation for the more complex scientific applications ●● Further optimisation of the functioning of

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).