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Vertaling van "trials by giving scientific " (Nederlands → Frans) :

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 “PRE pillar” supports the industry during the development of products, among other means by giving scientific advice and contributing to the compilation of pharmacopoeia monographs.

The “PRE pillar” supports the industry during the development of products, among other means by giving scientific advice and contributing to the compilation of pharmacopoeia monographs.


Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).

Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).


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.


Richtlijnen van de EFSA (Europese Voedselauthoriteit) voor de evaluatie van aroma’s zijn te vinden op haar website (WEB, Engels). Daarenboven zijn er ook “explanatory notes for guidance giving explanatory examples of scientific data needed for the risk assessment established in the EFSA Guidance” (WEB, in het Engels).

Des guidelines de l'EFSA (Autorité européenne de Sécurité des aliments) destinées à l'évaluation des arômes se trouvent sur son site internet (WEB, en anglais), où l'on trouve également des " explanatory notes for guidance giving explanatory examples of scientific data needed for the risk assessment established in the EFSA Guidance" (WEB, en anglais).


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


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: 2024-05-01
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