4 European Projects Found
Searched on 125080 European Projects
FINISHED
European Prevention of Alzheimer’s Dementia Consortium (EPAD)
Start date: Jan 1, 2015, End date: Dec 31, 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
Partners Participants
FINISHED
Incorporating real-life clinical data into drug development (GETREAL)
Start date: Oct 1, 2013, End date: Dec 31, 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
Partners Participants
FINISHED
SAFER AND FASTER EVIDENCE-BASED TRANSLATION (SAFE-T)
Start date: Jun 15, 2009, End date: Jun 14, 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
Partners Participants
FINISHED
Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT)
Start date: Sep 1, 2009, End date: Apr 30, 2015,
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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