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12 projets européens trouvés

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 TERMINÉ 

European Prevention of Alzheimer’s Dementia Consortium (EPAD)

Date du début: 1 janv. 2015, Date de fin: 31 déc. 2019,

Background:The secondary prevention of Alzheimer’s dementia (AD) is achievable if we can identify individuals at risk of disease progression defined by biomarker evidence of AD pathology and no or only minimal clinical symptoms and engage them in a standing adaptive clinical trial, of the highest quality, testing multiple interventions. To achieve this, EPAD will also provide the analytical infras ...
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 40

 TERMINÉ 

European Medical Information Framework (EMIF)

Date du début: 1 janv. 2013, Date de fin: 31 déc. 2017,

In response to the need to tackle increasingly complex medical research questions, a growing amount of human health data is being collected, either in routine Electronic Healthcare Record (EHR) databases, through research-driven cohort studies, in biobanks or related efforts. However, data sources are typically fragmented and contain information gaps which prevent their full exploitation. EMIF aim ...
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 64

 TERMINÉ 
The QuIC-ConCePT consortium has 2 objectives: 1.(90% of resource, WP2-5) to qualify 3 specific imaging biomarkers (IBs) of tumour cell proliferation, apoptosis, and necrosis, to allow drug developers to demonstrate reliably modulation of these pathologic processes in tumours in patients in realistic trials. Our vision for January 2016 is that drug developers can incorporate these IBs for decision- ...
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 26

 TERMINÉ 

Recognising Adverse Drug Reactions (WEB-RADR)

Date du début: 1 sept. 2014, Date de fin: 31 août 2017,

WEB-RADR is a consortium of leading experts in pharmacovigilance from regulatory agencies, research, academia and patient support groups. Together with EFPIA partners our aims will be to set policy & guidance and deliver robust information technology tools to address the potential for the reporting of adverse drug reactions (ADRs) through mobile applications and the recognition of drug safety sign ...
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 20

 TERMINÉ 

European Patients' Academy on Therapeutic Innovation (EUPATI)

Date du début: 1 févr. 2012, Date de fin: 31 janv. 2017,

"The proposed project ""European Patients' Academy on Therapeutic Innovation"" (EUPATI) contributes to IMI’s goal of raising patients’ awareness and participation in pharmaceutical R&D. This patient-led academy will provide scientifically reliable, objective, comprehensive information to patients on pharmaceutical R&D. It will increase the capacity of well-informed patients to be effective advocat ...
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 33

 TERMINÉ 

Incorporating real-life clinical data into drug development (GETREAL)

Date du début: 1 oct. 2013, Date de fin: 31 déc. 2016,

When a new medicine reaches the market, it is accompanied by an extensive data package that provides information about the safety and efficacy of the medicine in a clinical trial setting. However, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA ...
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 32

 TERMINÉ 

European programme in Pharmacovigilance and Pharmacoepidemiology (EU2P)

Date du début: 1 sept. 2009, Date de fin: 30 juin 2016,

The Eu2P training network in Pharmacovigilance and Pharmacoepidemiology will meet the needs of industry,regulatory authorities and academia at the European level. It will give access to a harmonised training programme that gathers complementary specialized and eminent European partners. The Eu2P consortium consists of course providers with aproven record including the University of Bordeaux (Eu2P ...
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 24

 TERMINÉ 

Electronic Health Record systems for Clinical Research (EHR4CR)

Date du début: 1 mars 2011, Date de fin: 29 févr. 2016,

Current medical needs, the growth of targeted therapies and personalized medicines, and escalating R&D costs result in formidable cost pressures on healthcare systems and the pharmaceutical industry. Clinical research is also growing in complexity, labour intensity and cost. There is a growing realization that the development and integration of Electronic Health Record systems (EHRs) for medical ...
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 37

 TERMINÉ 

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED)

Date du début: 1 oct. 2009, Date de fin: 30 sept. 2015,

RationaleThe inability of pre-clinical studies to predict clinical efficacy is a major bottleneck in drug development. In severe asthma this bottleneck results from: a lack of useful and validated biomarkers, underperforming pre-clinical models, inadequate and incomplete sub-phenotyping, and insufficient disease understanding.HypothesisThe use of biomarker profiles comprised of various types of hi ...
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 42

 TERMINÉ 

SAFER AND FASTER EVIDENCE-BASED TRANSLATION (SAFE-T)

Date du début: 15 juin 2009, Date de fin: 14 juin 2015,

The public-private consortium composed of complementary SMEs, academic and clinical centers of excellence and EMEA as partner proposes SAFE-T (Safer And Easter Evidence-based Iranslation) project for the establishment of a biomarker (BM) qualification process and its validation in clinical biomarker studies designed for the translation, performance testing and eventual regulatory qualifIcatIon of ...
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 26

 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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 36

 TERMINÉ 

Pharmaceutical Medicine Training Programme (PHARMATRAIN)

Date du début: 1 mai 2009, Date de fin: 30 avr. 2014,

"The proposed Pharmaceutical Medicine Training Programme provides a comprehensive solution for the complex needs of integrated drug development for all professionals involved, incl. physicians, pharmaceutical scientists,biologists, biometricians, health economists, and safety and regulatory scientists from universities, regulatory agencies, large, middle-sized and small pharmaceutical enterprises, ...
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 52