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Clinical trials will start in July for this vaccine.

Traduction de «clinical trial to start » (Néerlandais → Français) :

Committee is primarily concerned with the ethical and medical aspects, and is the body that has to provide explicit authorisation to allow a clinical trial to start.

Committee is primarily concerned with the ethical and medical aspects, and is the body that has to provide explicit authorisation to allow a clinical trial to start.


Clinical trials will start in July for this vaccine.

Les essais cliniques de ce vaccin débuteront en juillet.


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.


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)


However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.

However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.


The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.


In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.

In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.


Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.

Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.


- 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


One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.

One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.




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Date index: 2023-05-10
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