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Vertaling van "trials ●● gcp ●● scientific " (Nederlands → Frans) :

The R&D (research and development) department is constructed around the following three roles: ●● Clinical trials ●● GCP ●● Scientific advice

The R&D (research and development) department is constructed around the following three roles: ●● Clinical trials ●● GCP ●● Scientific advice


" Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.‰

ÿ Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the princinciples that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Ÿ


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


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.


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: 2022-05-04
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