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Vertaling van "clinical trial evaluating " (Nederlands → Frans) :

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.


‐ The Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.

the performance and safety of platelets treated with MIRASOL pathogen reduction technology.


Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.

Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.


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 FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.


Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.

Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.


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


- 2 e waarneming Definitief stoppen Niet van toepassing * Volgens de “National Cancer Institute of Canada Clinical Trial Group” (NCIC CTG) Common Toxicity Criteria (versie 1) van de “Common Terminology Criteria for Adverse Events” (CTCAE) van het “Cancer Therapy Evaluation Program, US National Cancer Institute, versie 3.0”.

- 2 e apparition Arrêter le traitement définitivement Sans objet * Conformément aux critères de toxicité du NCIC CTG (National Cancer Institute of Canada Clinical Trial Group) (version 1) ou aux critères du CTEP (Cancer Therapy Evaluation Program) pour les CTCAE (Common Terminology Criteria for Adverse Events) du programme d’évaluation des traitements anticancéreux de l’US National Cancer Institute (version 3.0).


The FAMHP wants: ●● To emerge as a point of reference for scientific advice ●● To attract clinical trials ●● To act as rapporteur or RMS in the evaluation of registration applications for important products ●● Where relevant, to be a point of reference

The FAMHP wants: ●● To emerge as a point of reference for scientific advice ●● To attract clinical trials ●● To act as rapporteur or RMS in the evaluation of registration applications for important products ●● Where relevant, to be a point of reference




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Date index: 2021-02-20
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