Tuscany Regional Health Agency's projects and collaborations: EU international research

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Over the last years the Tuscany Regional Health Agency (ARS) has significantly expanded its access to external funding for research, also thanks to the growing opportunities represented by European tenders. In particular, the European Commission, besides pure research, encourages different activities such as the exchange of good practices, the transferability of models of excellence and the impact evaluation for policies and interventions, aiming to increase population health status and quality of life through public policies increasingly oriented towards efficiency and sustainability.

The continuous updating on European policies and on calls published by the EU has favored the growth of ARS international research and significantly helped in finding the most appropriate collaboration opportunities according to the regional strategic lines.

The Agency's international collaborations, both in the context of EU-funded projects and in the context of collaborative research and pharmaco-epidemiology networks (such as ENCePP European Network of Centres for Pharmacoepidemiology and Pharmacovigilance and VCAC4EU - Vaccine monitoring Collaboration for Europe association) have thus increased significantly. In particular, the emergence and spread of the Covid 19 pandemic made it necessary to carry out timely preliminary studies for vaccines authorization and specific post-authorization studies, most of them currently participated by ARS.

Today ARS collaborates in a significant number of international research projects and seeks the creation and implementation of synergies with the best national and international research networks.

Project Call Agency's role Project status Official website of the project
Post Authorization Safety Study on AZZD1222 AstraZeneca UK Ltd vaccine for COVID 19 In collaboration with Research Triangle Institute – RTI Health solutions Partner in the research consortium Ongoing https://www.encepp.eu/encepp_studies/indexRegister.shtml

Post Authorization Safety Study on Moderna Biontech mRNA-1273 vaccine for COVID 19 In collaboration with  Julius Clinical Study agreement Partner in the research consortium Ongoing https://www.encepp.eu/encepp_studies/indexRegister.shtml

EMA study on “Early safety monitoring of Covid-19 vaccines in the EU” Reopening of EMA tender EMA/2018/28/PE Partner in the research consortium Ongoing https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass-0

Post Authorization Safety Study on Pfizer-BioNTech tozinameran vaccine (Comirnaty®) In collaboration with Fondazione PENTA onlus Partner in the research consortium Ongoing https://www.encepp.eu/encepp_studies/indexRegister.shtml
EMA study “MINERVA - Strengthening use of real-world data in medicines development - metadata for data discoverability & study replicability” Subcontractor Ongoing https://www.encepp.eu/encepp/viewResource.htm?id=39323
EMA study on
“Efficacy and safety associated with use of Valproate and oral rethinoids in pregnancy and brestfeeding”
EMA/2017/09/PE (lots 1, 3 e 4) Partner in the research consortium Ongoing https://etendering.ted.europa.eu/cft/cft-display.html?cftId=2506

Joint Action on implementation of Digitally Enabled integrated person-centred CARE
Joint Action CHAFEA Grants (HP-JA)  Affiliated Entity  of Agenas Ongoing https://jadecare.eu/
Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation
Partner in the research consortium Ongoing https://www.imi-conception.eu/ 

Pregnant COVID-19
EMA study on
“CONSIGN Impact of COVID-19 infection and medicines in pregnancy”
Reopening of EMA Procurement Procedure
No. EMA/2017/09/PE (lot 4)
Partner in the research consortium  Ongoing https://www.ema.europa.eu/en/news/covid-19-ema-sets-infrastructure-real-world-monitoring-treatments-vaccines
Data linkage cost analysis for each registry
Third linked party to CNR
Concluded https://www.eurolinkcat.eu/
EMA study
on "Risk of cardiac valve disorders associated with the use of biphosphonates"
Procurement procedure no. EMA/2011/39/CN Partner in the research consortium) Concluded
EMA study on Patterns and Determinants of Use of Oral Contraceptives in the EU Procurement procedure no. EMA/2011/37/CN Partner in the research consortium Concluded
Feasibility analysis of an EU infrastructure for COVID-19 vaccine monitoring
Procurement procedure no.
Partner in the research consortium Concluded https://www.ema.europa.eu/en/news/ema-commissions-independent-research-prepare-real-world-monitoring-covid-19-vaccines
Accelerated Development of VAccine beNefit-risk Collaboration in Europe
Partner in the research consortium   Concluded https://www.imi.europa.eu/content/advance 
European Medical Information Framework
Innovative Medicines Initiative - IMI1 - Call 4 Partner in the research consortium     Concluded  http://www.emif.eu/ 
Exploring and understanding adverse drug reactions by integrative mining of clinical records and biomedical knowledge
EU 7th Framework research programme  Partner in the research consortium Concluded   https://cordis.europa.eu/project/id/215847/it 
Alcohol Measures for Public Health Research Alliance
EU 7th Framework research programme Partner in the research consortium   Concluded   https://www.amphoraproject.net/ 
Narcolepsy - Influenza, Influenza Vaccination and Narcolepsy: Background rates and case control study
European Centre for Disease Prevention and Control
Subcontractor Concluded    https://www.ecdc.europa.eu/en/news-events/ecdc-vaesco-investigation-narcolepsy 
Clinical Leading Environment for the Assessment and validation of Rehabilitation protocols for home care
EU 7th Framework research programme  Tuscany Region's subcontractor   Concluded  https://www.clear-project.eu/ 
Health and social services: a volunteer quality system
PROGRESS Call - Transnational project of experimentation in social matters
ESF - VP / 2009/005
Beneficiary partner   Concluded https://ec.europa.eu/employment_social/defis/publigrant/public/publications/541/frame/
Observational Medical Outcomes Partnership
PP partnership Public-private partnership Concluded https://www.ars.toscana.it/aree-di-intervento/demografia-e-salute/farmacoepidemiologia/1371-observational-medical-outcomes-partnership-experiment.html
Joint Action on Health Inequalities 
Executive Agency for Health and Consumer (EACH) - Joint Action EA - 20102203 Subcontractor of Verona University Hospital on WP4 Concluded https://eurohealthnet.eu/hpe/equity-action-joint-action
Health Care Reform: the iMpact on practice, oUtcomes and costs of New roles far health pROfeSsionals
FP7-HEALTH Subcontractor of Catholic University Sacro Cuore Concluded  https://cordis.europa.eu/project/id/305467