Vertaling van "for the evaluation and approval " (Nederlands → Frans) :

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Evaluation commission for medicines for human use Evaluation commission for medical devices preliminary approvals for scientific events
Evaluation commission for medicines for human use Evaluation commission for medical devices preliminary approvals for scientific events

Reclast/Aclasta, approved for five indications, gained additional US approval in May as the only therapy to prevent postmenopausal osteoporosis with convenient, less-frequent dosing, while European approval was granted in June for treatment of osteoporosis caused by steroid treatment in men and postmenopausal women, an indication already approved in the US.
Autorisé pour cinq indications, Aclasta/Reclast a obtenu en mai des autorisations supplémentaires aux Etats-Unis en tant que seul traitement pratique et peu fréquent destiné à prévenir l’ostéoporose postménopausique. En Europe, l’autorisation a été accordée en juin pour le traitement de l’ostéoporose provoquée par des stéroïdes chez l’homme et la femme postménopausée, indication déjà homologuée aux Etats-Unis.

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.

It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.
It is the R&D department’s role to protect the participants in clinical trials by giving scientific advice and evaluating, approving, monitoring and checking applications for clinical research, on the basis of sound scientific knowledge.

The European Directive 2001/20, transposed in the law of 7 May 2004, forms the basis for the department’s core tasks: ●● Validating, evaluating and assigning approvals for the conduct of clinical trials (including declarations) ●● Strategic preparation of the associated GCP
The European Directive 2001/20, transposed in the law of 7 May 2004, forms the basis for the department’s core tasks: ●● Validating, evaluating and assigning approvals for the conduct of clinical trials (including declarations) ●● Strategic preparation of the associated GCP

Evaluating and approving amendments
Evaluating and approving amendments

In February, this therapy for mild to moderate forms of Alzheimer’s disease dementia (approved in Europe) as well as dementia linked with Parkinson’s disease (approved in the US) was also submitted for regulatory approval in Japan.
Exelon/Exelon Patch est un traitement des formes légères à modérées de la maladie d'Alzheimer et de la démence associée à la maladie de Parkinson. La première indication a été autorisée en Europe et la seconde, aux Etats-Unis, tandis qu’une demande d’homologation a aussi été déposée en février au Japon.

Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (October 2009); resubmission planned by end 2010 Approved Q4 2009 Q1 2010 - FDA approval received after priority review
- Feed-back des autorités attendu au T4 2010 T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue avant fin 2010 Autorisé T4 2009 T1 2010 - Autorisation de la FDA après revue prioritaire

MRP IA: datum van implementatie zoals aangegeven in het antwoord op vraag 5.2 MRP IB: approval date van de RMS MRP II: approval date van de RMS
MRP IA : date d’implémentation telle qu’indiquée dans la réponse à la question 5.2 MRP IB : approval date du RMS MRP II : approval date du RMS