Traduction de «regulatory decisions have been achieved » (Néerlandais → Français) :

More than 30 positive regulatory decisions have been achieved to date in 2009 in the US, European Union and Japan.
Plus de trente décisions réglementaires favorables ont été accordées à ce jour en 2009 aux Etats-Unis, dans l’Union européenne et au Japon.

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.

Achieving success with long-term R&D investments Novartis has been reaping the benefits of long-term, disciplined investments in innovation, achieving more than 30 major regulatory approvals and significant progress in the Group’s R&D pipeline so far in 2009.
Succès des investissements à long terme dans la R&D Novartis a récolté les fruits d'investissements judicieux à long terme dans l'innovation. Il a en effet obtenu plus de 30 autorisations majeures de mise sur le marché et réalisé à ce jour en 2009 d’importants progrès dans le pipeline de R&D du Groupe.

Regulatory submissions have also been completed in Japan and China.
Des demandes d’autorisation ont été également déposées au Japon et en Chine.

Some achievements and figures for Unit II in 2007 Rapid alerts relating to the quality of medicines The Rapid Alerts System or RAS network is an international network whose purpose is to circulate information as quickly as possible about batches of medicines that have been identified as nonconforming, which were produced in non-GMP conditions or which do not belong to the distribution circuit that complies with the GDP.
Some achievements and figures for Unit II in 2007 Rapid alerts relating to the quality of medicines The Rapid Alerts System or RAS network is an international network whose purpose is to circulate information as quickly as possible about batches of medicines that have been identified as nonconforming, which were produced in non-GMP conditions or which do not belong to the distribution circuit that complies with the GDP.

To achieve results as quickly as possible, a number of levers have been determined by the Central Working Group for the development of the new organisation.
To achieve results as quickly as possible, a number of levers have been determined by the Central Working Group for the development of the new organisation.

In order to achieve the strategic objectives, some 70 PMO projects (e.g. self-inspection, risk management) have been defined.
In order to achieve the strategic objectives, some 70 PMO projects (e.g. self-inspection, risk management) have been defined.

As a result of this lack of availability, the care provided is often restricted to a vague nosographic diagnosis and a decision to admit the patients in question to the psychiatric department (the cost of which might have been saved) or to send them to a consultation. Attention is only paid to the “identified patient” rather than to devising a real therapeutic follow-up that involves the complete system.
Par ce manque de disponibilité, l’intervention se limite souvent à un vague diagnostic nosographique et à une décision d’hospitalisation en service de psychiatrie (dont on aurait pu faire l’économie) ou d’envoi en consultation, portant leur attention sur le seul « patient désigné » plutôt que d’amorcer un véritable suivi thérapeutique avec l’ensemble du système. ♦ une méconnaissance des ressources du réseau psychosocial: « Travailler avec