Vertaling van "applications and their decisions regarding labeling " (Frans → Nederlands) :

This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; 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 uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

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.
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.

En fait, c'est peut-être même l'information la plus sensible qui soit, et si de nouvelles découvertes sont faites et que les connaissances avancent sur ce que vos gènes disent de vous, cette information deviendra probablement toujours davantage sensible au fil du temps.], centrale ou périphérique « Individuals want to have a more active role in the creation, storage and protection of their personal genetic information [traduction libre: Les gens veulent prendre une part plus active dans la genèse, la conservation et la protection de leurs données génétiques personnelles] ; les conséquences logiques de « Not supplying genetic testing services direct-to-the-public to those under the age of 16 or to those not able to make a competent decision regarding testing » [traduction libre: Ne pas fournir des tests génétiques en vente directe aux personnes âgées de moins de 16 ans ou aux personnes qui n'ont pas la capacité de prendre une décision en matière de dépistage] sur le champ d'application vraisemblablement le plus sollicité actuellement en médecine embryonnaire et fœtale : « That the DTC offer of preconceptional carrier testing questions the offer of preconception care and the systematic offer of carrier tests towards a population of couples that are planning a pregnancy.
In fact, it may be the most sensitive information there is and as new discoveries are made, and more is learned about what your genes say about you, this information is likely to become ever more sensitive over time" , centraal of perifeer: " Individuals want to have a more active role in the creation, storage and protection of their personal genetic information" , of aan de logische gevolgen van: " Not supplying genetic testing services direct-to-the-public to those under the age of 16 or to those not able to make a competent decision regarding testing" , op het huidige waarschijnlijk al meest gevraagde toepassingsgebied in de embryonale en foetale geneeskunde: " That the DTC offer of preconceptional carrier testing questions the offer of preconception care and the systematic offer of carrier tests towards a population of couples that are planning a pregnancy.

Only 26% would choose to inform the patient outside the existing organs, and with a stronger preference on informing after the decision is taken. In the first scenario, there is no significant difference between the respondents with regard to the choice of the place where the information is given (inside or outside the existing decision-making organs) according their current/past membership (or not) of the INAMI – RIZIV organs.
In the first scenario, there is no significant difference between the respondents with regard to the choice of the place where the information is given (inside or outside the existing decision-making organs) according their current/past membership (or not) of the INAMI – RIZIV organs.