Traduction de «famhp is responsible for the evaluation and approval of clinical » (Néerlandais → Français) :

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 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.

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (October 2009); resubmission planned by end 2010 Approved Q4 2009 Q1 2010 - FDA approval received after priority review
- Feed-back des autorités attendu au T4 2010 T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue avant fin 2010 Autorisé T4 2009 T1 2010 - Autorisation de la FDA après revue prioritaire

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.

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.

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.

QAB149 COPD Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (Q4 2009), resubmission planned for 2010
QAB149 BPCO T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue en 2010

- 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