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Vertaling van "that the clinical trial data " (Nederlands → Frans) :

" 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


However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.

However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.


- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September

2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA


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.


Committee is primarily concerned with the ethical and medical aspects, and is the body that has to provide explicit authorisation to allow a clinical trial to start.

Committee is primarily concerned with the ethical and medical aspects, and is the body that has to provide explicit authorisation to allow a clinical trial to start.


The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.

The law of 7 May 2004 relating to experiments on the human person in Belgium provides that any objections from the FAMHP need to be submitted within a maximum of 28 days following the validation of applications for clinical trials.


There is one other fee that is notable for its intended purpose, since the “clinical trial” contribution (1,670,042 euros) will serve not just to cover the FAMHP’s costs but also and above all to finance the Ethics Committees. As far as the taxes are concerned, it should be

There is one other fee that is notable for its intended purpose, since the “clinical trial” contribution (1,670,042 euros) will serve not just to cover the FAMHP’s costs but also and above all to finance the Ethics Committees. As far as the taxes are concerned, it should be


If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.

If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.


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.


Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and bupropion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.

Unit cost: €2.53 Costs of interventions in current practice based on Dutch empirical data Cost calculations of interventions in increased implementation program based on Dutch practice guidelines and (for the duration of NRT and Buproprion) on international trials (Cochrane meta-analysis) Costs of smoking-related diseases were taken into account, estimates based on Dutch cost-ofillness study that allocated total direct health care costs to diseases.




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Date index: 2023-02-21
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