Vertaling van "authorities in other member " (Nederlands → Frans) :

The reason behind this ambition is certainly not obvious: the competent medicines authorities in other Member States have the same ambition and vaccinology is, in epidemiological terms, a very broad domain, ranging from the prevention of neonatal pathology to hospital infections to sexually transmitted diseases.
The reason behind this ambition is certainly not obvious: the competent medicines authorities in other Member States have the same ambition and vaccinology is, in epidemiological terms, a very broad domain, ranging from the prevention of neonatal pathology to hospital infections to sexually transmitted diseases.

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.

This means there is a given amount of competition between the competent medicines authorities in the various European Member States for evaluating files such as these.
This means there is a given amount of competition between the competent medicines authorities in the various European Member States for evaluating files such as these.

This allows each member of staff to declare any financial or other interests in organisations or companies falling within the FAMHP mission and obliges members of staff to inform the Agency immediately of any significant changes occurring to those interests.
This allows each member of staff to declare any financial or other interests in organisations or companies falling within the FAMHP mission and obliges members of staff to inform the Agency immediately of any significant changes occurring to those interests.

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.
The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.

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.
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.

since March 2008. This database is an important tool used by the FAMHP departments/services in the context of their activities as well as by the BUM Department itself in order to answer the numerous questions posed by healthcare professionals, patients/consumers, relevant industry or other national or foreign authorities.
since March 2008. This database is an important tool used by the FAMHP departments/services in the context of their activities as well as by the BUM Department itself in order to answer the numerous questions posed by healthcare professionals, patients/consumers, relevant industry or other national or foreign authorities.

To ensure the population the optimal use of the medicines and health products they need, the FAMHP’s team manages, in a recognised, effective and responsible manner, all aspects of this area in consultation with all relevant parties in the health sector and the other national and international authorities.
To ensure the population the optimal use of the medicines and health products they need, the FAMHP’s team manages, in a recognised, effective and responsible manner, all aspects of this area in consultation with all relevant parties in the health sector and the other national and international authorities.

Recognition by the relevant parties at national level and by the other competent authorities at European level for early phase development has without a doubt been a significant achievement for the R&D department and the FAMHP.
Recognition by the relevant parties at national level and by the other competent authorities at European level for early phase development has without a doubt been a significant achievement for the R&D department and the FAMHP.