Traduction de «department is responsible for evaluating » (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 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.

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 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.

The Registration (marketing authorisation) department for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).
The Registration (marketing authorisation) department for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).

It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.
It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.

The European Directive 2001/20, transposed in the law of 7 May 2004, forms the basis for the department’s core tasks: ●● Validating, evaluating and assigning approvals for the conduct of clinical trials (including declarations) ●● Strategic preparation of the associated GCP
The European Directive 2001/20, transposed in the law of 7 May 2004, forms the basis for the department’s core tasks: ●● Validating, evaluating and assigning approvals for the conduct of clinical trials (including declarations) ●● Strategic preparation of the associated GCP

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).