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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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TERMINÉ
Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT)
Date du début: 1 sept. 2009, Date de fin: 30 avr. 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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