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4 projets européens trouvés

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 TERMINÉ 

Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE)

Date du début: 1 oct. 2013, Date de fin: 30 sept. 2018,

Aim: The ADVANCE vision is focused on Timely and Best Evidence on Vaccine Effects. Our mission is to establish a best practice framework to rapidly provide robust data on vaccine benefits and risks to support accelerated decision-making.Approach: To achieve this vision through a public-private partnership, ADVANCE partners 1. establish common grounds and rules for collaboration between public and ...
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 TERMINÉ 

Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)

Date du début: 1 oct. 2011, Date de fin: 30 sept. 2015,

"In 2010 a widely marketed drug for the treatment of type 2 diabetes (T2DM) (rosiglitazone) was taken from the market as it was associated with an increased risk of myocardial infarction, a T2DM complication it was actually supposed to prevent. This example shows several things. First, the approval requirements do not guarantee a longer term positive benefit risk profile. Second, large scale postm ...
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 TERMINÉ 
Recent pharmacovigilance (PV) issues have led to questions regarding the ability of the current PV system to meet the global needs. Controversies around the assessment of spontaneous reports and conflicting results from pharmacoepidemiology studies may lead to delay in, or inappropriate, regulatory decisions. The PROTECT consortium, consisting of 20 core partners lead by the European Medicines Age ...
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 TERMINÉ 
"European clinical research needs an integrated and distributed infrastructure able to provide efficient support to multinational clinical trials, taking advantage of the European population and competencies, unlocking latent expertise and patients scattered across the EU member states. ECRIN (European Clinical Research Infrastructures Network) is designed to bridge the fragmentation of clinical r ...
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