Objective
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 Agency (EMEA), will
develop and test methods of proactive monitoring of drug safety and benefit risk (B/R) assessment utilising a large range of EU data sources and expertise. in partnership with EFP1A companies, PROTECT will develop essential parameters, methodologies and algorithms to enable data mining, signal detection and evaluation in various types of
data-sets including spontaneous reporting, registries and electronic health care databases (EHR). impact analysis
methods will be used to enhance signal prioritisation.
PROTECT will develop means of combining results from clinical trials, spontaneous reporting and observational data, strengthening continuous B/R monitoring in the post-authorisation phase. Bayesian modelling, multi-criteria decision analysis and other analytical methods will be compared. Methods for graphical expression of B/R will be
tested with different stakeholders.
Collection of data directly from patients is underutilized and may be essential when knowledge of total drug consumption or potential confounders is needed or conventional PV is disrupted. PROTECT will trial direct patient data collection in natural language using web-based, telephone and text messaging systems. As well as testing
transferability of the data into a common language, PROTECT will explore linkage to data from EHR and electronic registries.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- medical and health sciences basic medicine pharmacology and pharmacy drug safety
- medical and health sciences health sciences health care services eHealth
- natural sciences computer and information sciences databases
- natural sciences computer and information sciences data science data mining
- engineering and technology environmental engineering energy and fuels renewable energy solar energy photovoltaic
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
IMI-JU-01-2008
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)
Coordinator
1083 HS Amsterdam
Netherlands
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Participants (34)
2300 Copenhagen S
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WC1A 1DG LONDON
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SE1 7QY London
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1162 St. Prex
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80539 MUNCHEN
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28022 Madrid
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08035 Barcelona
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28004 Madrid
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75654 PARIS
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75015 Paris
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20156 Milano
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9712CP Groningen
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3584 CS Utrecht
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S-75140 Uppsala
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LS2 7UE Leeds
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SW7 2AZ LONDON
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NE1 7RU Newcastle Upon Tyne
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94250 Gentilly
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CT13 9NJ Sandwich
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4070 Basel
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4056 Basel
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1831 Diegem
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1411 DD Naarden
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64293 Darmstadt
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13353 Berlin
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151 85 Sodertaelje
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2500 Valby
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2880 Bagsvaerd
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61-701 POZNAN
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WC2B 4AE London
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8000 Aarhus C
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RG21 4FA BASINGSTOKE
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58455 Witten
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9713 GZ Groningen
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