Traduction de «positive regulatory decisions have been » (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.

European approval is expected in early 2010 after a positive opinion in December 2009, while a US regulatory decision is also expected in the first half of the year.
En Europe, une autorisation devrait être délivrée début 2010, après un avis favorable émis en décembre 2009, tandis qu’une décision est également attendue au premier semestre aux Etats-Unis.

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.

Meanwhile, several two-day trainings have been organised, which have been shown to be adapted to concrete reality and have been given very positive evaluations.
Les évaluations démontrent que ces formations sont adaptées à la réalité concrète et elles sont très positives.

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

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

They also aim to find out whether the patients are satisfied with the help provided, whether the latter intend to consult their GP in case of a crisis, what their present psychosocial functioning is and whether there were any recurrences of suicidal behaviour. The psychosocial functioning is measured by means of the following instruments (which have been validated internationally): the General Health Questionnaire (GHQ12), the Beck Hopelessness Scale (BHS), the Positive and Negative Affectivity Scale (PANAS).
Le fonctionnement psychosocial est mesuré à l’aide des instruments suivants (validés internationalement): General Health Questionnaire (GHQ12), l’échelle de Beck, qui évalue l’anxiété et la dépression, Positive and Negative Affectivity Scale (PANAS).

According to the WHO, eight domains have been identified in which this type of action can be taken, i.e. making employers more aware of mental health issues, identifying the common goals and positive aspects of the job, creating a balance between job demand and professional competence, training social competence, improving the psychosocial climate in the work place, giving advice to employees, improving the ability to work as well as strategies for early rehabilitation, improving work opportunities.
Selon l’OMS, huit domaines d’action ont été recensés à cet égard: sensibilisation accrue de l’employeur aux problèmes de santé mentale; identification de buts communs et d’aspects positifs du travail; équilibrage entre la demande d’emploi et les compétences professionnelles; formation aux aptitudes sociales; développement du climat psychosocial du lieu de travail; conseils dispensés aux travailleurs; amélioration de la capacité de travail et stratégies de réadaptation précoce, amélioration des opportunités d’emploi.

Furthering the delayering efforts, three executive positions have been eliminated: COO, Head Corporate Affairs, and Head Group Quality/Technical Operations.
Dans la poursuite des efforts visant à aplatir la hiérarchie, trois positions dirigeantes ont été éliminées: direction opérationnelle, direction Corporate Affairs et direction Opérations technique et Qualité du Groupe.