Traduction de «clinical and preclinical development » (Néerlandais → Français) :

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.

European Group on Ethics in Science and New Technologies; [http ...]
European Group on Ethics in Science and New Technologies; [http ...]

The development of a medicine is a continuous process where the finetuning of the chemical–pharmaceutical process and the preclinical and clinical tests both occur in parallel and influence each other.
The development of a medicine is a continuous process where the finetuning of the chemical–pharmaceutical process and the preclinical and clinical tests both occur in parallel and influence each other.

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.

Mace Rothenberg, Senior Vice President, Clinical Development and Medical Affairs bij Pfizer, is het daarmee eens: “Men kan met zekerheid zeggen dat de tumorgeneeskunde een pioniersrol speelt in de evolutie naar een gepersonaliseerde geneeskunde.
Mace Rothenberg, Senior Vice President, Clinical Development and Medical Affairs au sein de Pfizer, le confirme en ces termes : « On peut incontestablement affirmer, sans risque de se tromper, que la médecine anticancéreuse a un rôle pionnier dans la médecine personnalisée.

Interview met Mace Rothenberg, Senior Vice President Clinical Development and Medical Affairs – Pfizer Oncology
Interview avec Mace Rothenberg, Senior Vice President Clinical Development and Medical Affairs – Pfizer Oncology

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

To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.
To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.

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 R&D (research and development) department is required to deal with all relevant applications for clinical trials.
The R&D (research and development) department is required to deal with all relevant applications for clinical trials.