Vertaling van "approvals clinical trials " (Nederlands → Frans) :

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

R&D maintains momentum: Anti-cancer therapy Afinitor introduced in the US, awaiting EU approval; new biologic Ilaris and OTC brand Prevacid 24HR gain US approvals; clinical trials set to start in July for A(H1N1) pandemic flu vaccine
R&D maintient son élan: Afinitor, traitement anticancer lancé aux USA et en attente d’homologation dans l’Union européenne; Ilaris, nouveau médicament biologique, et Prevacid 24HR, vendu sans ordonnance, tous deux autorisés aux Etats-Unis; début en juillet des essais cliniques d’un vaccin contre la pandémie de grippe A(H1N1)

inspections ●● Monitoring the approved clinical trials by:
inspections ●● Monitoring the approved clinical trials by:

QAB149 COPD Q4 2008 Approved - Clinical trials underway to address FDA Complete Response letter (Q4 2009), resubmission planned for 2010
QAB149 BPCO T4 2008 Autorisé - Essais cliniques en cours pour répondre à la « complete response letter » de la FDA (T4 2009), nouvelle demande prévue en 2010

- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September
2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA

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.

More than 30,000 people were enrolled in A (H1N1) pandemic vaccine clinical trials, while three different technology platforms (traditional egg-based, cell-culture-based and MF-59 adjuvanted vaccines) received regulatory approvals to maximize the vaccine supply.
Plus de 30 000 personnes ont été engagées dans les essais cliniques de ce vaccins, tandis que trois plateformes faisant appel à des technologies différentes (traditionnelle à base d’œufs, culture cellulaire et adjuvantation par MF-59) ont été autorisées afin de maximaliser les quantités livrées.

If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.
If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.

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

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.