Traduction de «evaluation and approval of clinical research activities » (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.

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

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.

This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.

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

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.

1. [PDF] De poster " Development, Implementation and Evaluation of the Activity of Clinical Pharmacy through the Results of 54 Pilot Projects" (R.
1. [PPT] Le poster " Development, Implementation and Evaluation of the Activity of Clinical Pharmacy through the Results of 54 Pilot Projects" (R.

21. Netwerk MFC : Development, Implementation and Evaluation of the Activity of Clinical Pharmacy through the Results of 54 Pilot Projects (PDF)
21. Réseau des Comités Médicopharmaceutiques : Development, Implementation and Evaluation of the Activity of Clinical Pharmacy through the Results of 54 Pilot Projects (PDF)