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Our team has a proven track record of scientific and management work and have contributed to several publications.

Publications & Reports

Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study

Authors: Sharifa Nasreen, Yannan Jiang, Han...Gianmarco Di Mauro, Miriam CJM Sturkenboom, Jim Buttery, Steven Black, Jeffrey C. Kwong.
Journal: Vaccine
Year: 2025
DOI: 10.1016/j.vaccine.2025.127291

Incidence of severe and non-severe SARS-CoV-2 infections in children and adolescents: a population-based cohort study using six healthcare databases from Italy, Spain, and Norway

Authors: Carlos E. Durán, Fabio Riefolo, Rosa Gini, Elisa Barbieri, Davide Messina, Patricia Garcia, Mar Martin, Felipe Villalobos...Hedvig Nordeng & Miriam Sturkenboom
Journal: European Journal of Paediatrics
Year: 2024
DOI: 10.1007/s00431-024-05864-1

Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study

Authors: Luxi, N., Ciccimarra, F., Bellitto, C., Raethke, M., van Hunsel, F., Lieber, T., Mulder, E., L’Abbate, L., Marques, F.B., Furci, F., Farcas, A., Giele-Eshuis, J., Morton, K., Sonderlichová, S., Thurin, N., Villalobos, F., Riefolo, F., Sturkenboom, M., & Trifirò, N.
Journal: Vaccines
Year: 2024
DOI: 10.3390/vaccines12091059

SAFETY-VAC study: A framework for the post-authorization SAFETY monitoring and evaluation of the VACcines in Europe

Authors: Durán, C. E., Gini, R., Davide, M., Riefolo, F., Riera, J., Hoxhaj, V., Mohammadi, S., Pazos Capell, I., Ehrenstein, V., Roberto, G., Souverein, P., Gardarsdottir, H., Giraldi, A., Hyeraci, G., Giaquinto, C., Barbieri, E., Stona, L., Villalobos, F., Solórzano, M., … Sturkenboom, M.
Journal: Zenodo
Year: 2024
DOI: 10.5281/zenodo.13384860

Unlocking Real-World Evidence in post marketing surveillance: The Critical Role of Scientific Management

Authors: Yeimenko, N., Palà, E., Molero, E., Riefolo, F., Di Mauro, G.
Year: 2024

Assessing the impact of data diversity on background incidence rates of adverse events of special interest: the component strategy from the COVID-19 Vaccine Monitoring project

Authors: Roberto, G., Messina, D., Durán, C.E., Riera-Arnau, J., Garcia, P., Martín-Pérez, M., Paoletti, O., Bissacco, C.A., Villalobos, F., Carreras, J.J., Mira, A., Souverein, P., Riefolo, F. , Klungel O.H., Sturkenboom, M.
Year: 2024
Presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology by Gini, R. August 28, 2024. Berlin, Germany

Cohort event monitoring of COVID-19 vaccine safety using patient-reported outcomes in lactating women

Authors: Maisonnueve, E., Ciccimarra, F., Luxi, N...Riefolo, F. , Villaolobos, F., Thurin, N., Marques, F., Morton, K., O’Shaughnessy, F., Sonderlichová, S., Farcas, A., Giele-Eshuis, J., Siiskonen, SJ., Baud, D., Sturkenboom, Panchaud, A., Trifirò, G.
Year: 2024
Presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology by Gini, R. August 28, 2024. Berlin, Germany

Cohort event monitoring of COVID-19 vaccine safety using patient-reported outcomes in pregnant women

Authors: Maisonnueve, E., Ciccimarra, F., Luxi, N...Riefolo, F. , Villaolobos, F., Thurin, N., Marques, F., Morton, K., O’Shaughnessy, F., Sonderlichová, S., Farcas, Siiskonen, SJ., Baud, D., Giele-Eshuis, J., Sturkenboom, M., Trifirò, G., Panchaud, A.
Year: 2024
Presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology by Gini, R. August 28, 2024. Berlin, Germany

Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe

Authors: Weibel, D., de Luise, C., Royo, A...Yefimenko, N., Palà, E....Garg, R., Rubino, H., Sturkenboom, M., Arana, A.
Year: 2024
Presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology by Gini, R. August 28, 2024. Berlin, Germany

Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European Healthcare Data Sources: Methods and Results of the Second Study Feasibility Assessment

Authors: Ahmadicar, F., Fortuny, J., Royo, A... Boric, K., Yefimenko, N., Haugh, M., Carreras, J., Urchueguía-Fornes, A., Correcher, E., van den Berg, J., Lysen, T., Vilalobos, F., Bissacco, C., Newbern, E., Willame, C., Praet, N., Sturkenboom, M.
Year: 2024
Presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology by Gini, R. August 28, 2024. Berlin, Germany

What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study

Authors: Bellitto, C., Luxi, N., Ciccimarra, F...Riefolo, F., Villaolobos, F., Thurin, N., Marques, F., Morton, K., O’Shaughnessy, F., Sonderlichová, S., Farcas, A., Janneke, G., Sturkenboom, M., Trifirò, G.
Journal: Drug Safety
Year: 2024
DOI: 10.1007/s40264-024-01449-x

The Validation Of COVID-19 Information In The Pharmacoepidemiological Research Database of Spain’s Public Health System Data by Vaccination Status

Authors: Astasio, O., Castillo-Cano, B., Sánchez Delgado, B., Riefolo, F., Gini, R. & Martín-Merino, E.
Journal: Perspectives in Health Information Management
Year: 2024
DOI: 40135710

A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases

Authors: Schultze, A., Martin, I., Messina, D... Riefolo, F. , Durán, C. E., Gini, R., Sturkenboom, M., … Douglas, I.
Journal: Vaccine
Year: 2024
DOI: 10.1016/j.vaccine.2024.03.043

Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study

Authors: Raethke, M., van Hunsel, F., Luxi, N., Lieber, T., Bellitto, C., Mulder, E., Ciccimarra, F., Riefolo, F. , et al.
Journal: Vaccine
Year: 2024
DOI: 10.1016/j.vaccine.2024.03.001

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Authors: Ciccimarra, F., Luxi, N., Bellitto, C., L’Abbate, L., Raethke, M., van Hunsel, F., Lieber, T., Mulder, E., Riefolo, F., Dureau-Pournin, C., et al.
Journal: Vaccines
Year: 2024
DOI: 10.3390/vaccines12030241

Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Authors: Koenig, F., Spiertz, C., Millar, D., Rodríguez-Navarro, S., Machín, N., Dessel, A. van, Genescà, J., Pericàs, J. M., & Posch, M.
Journal: eClinicalMedicine
Year: 2023
DOI: 10.1016/j.eclinm.2023.102384

Effectiveness of homologous/heterologous booster COVID-19 vaccination schedules against severe illness in general population and clinical subgroups in three European countries

Authors: Riefolo, F., Castillo-Cano, B., Martín-Pérez, M...Villalobos, F., Ingrasciotta, Y., Garcia-Poza, P., Swart-Polinder, K., Souverein, P., Saiz, L. C., Bissacco, C. A., Leache, L., Tari, M., Crisafulli, S., Grimaldi, L., Vaz, T., Gini, R., … Martín-Merino, E.
Journal: Vaccine
Year: 2023
DOI: 10.1016/j.vaccine.2023.10.011

Real-world-evidence on different COVID-19 vaccines combinations’ effectiveness in six electronic healthcare data sources from four pan-European countries

Authors: Riefolo, F., Cano, B. C., Martin, M. M., Messina, D., Elbers, R., Brink-Kwakkel, D., Villalobos, F., Ingrasciotta, Y., Garcia-Poza, P., Swart-Polinder, K., Souverein, P., Carlos Saiz, L., Alberto Bissaccco, C., Leache, L., Tari, M., Crisafulli, S., Barbieri, E., Stona, L., Garcia de Albeniz, X., … Martin Merino, E.
Year: 2023
Poster presented at the 17th Vaccine Congress; 24-27 September 2023. Glasgow, Scotland

Myocarditis Associated with SARS-Cov-2 Vaccines by Dose and Brand in Three European Countries Using Large Electronic Health Care Data Sources: A Self-Controlled Risk Interval Study in the COVID-19 Vaccine Monitor Study

Authors: Durán, C., Belitser, S., Bots, S., Riefolo, F., Messina, D., Gini, R., García-Poza, P., Martín Pérez, M., José Carreras, J., Correcher-Martínez, E., Urchueguía, A., Souverein, P., Villalobos, F., Reira-Arnau, J., Schultze, A., Douglas, I., Klungel, O., & Sturkenboom, M.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Incidence of COVID-19 Disease Severity in a Cohort of 4.4 Million Italian and Spanish Children from 6 Healthcare Databases

Authors: Durán, C., Riefolo, F., Gini, R., Messina, D., García-Poza, P., Martín-Perez, M., Villalobos, F., Pallejà-Millán, M., Barbieri, E., Stona, L., Ingrasciotta, Y., José Carreras, J., Correcher-Martínez, E., Urchueguía, A., Tari, M., Lentile, V., & Sturkenboom, M.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Safety of COVID-19 Vaccines Among People with Prior History of SARS-Cov-2 Infection: Results from the COVID-Vaccine-Monitor Cohort Event Monitoring

Authors: Luxi, N., Raethke, M., Giele-Eshuis, J., Batel Marques, F., Busca, C., Morton, K., Riefolo, F., Sonderlichová, S., Thurin, N., Villalobos, F., Sturkenboom, M., & Trifirò, G.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Representation of Study Scripts to Improve Transparency and Efficiency in Multidatabase Distributed Vaccine Studies

Authors: Gini, R., Messina, D., Aarts, W., Paoletti, O., Bartolini, C., Weibel, D., Choi, J., Cid-Royo, A., Elbers, R., Andres Vaz, T., Belitser, S., Bots, S., Riefolo, F., Plana, E., & Sturkenboom, M.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Quality compliance while conducting NIS studies: critical success factors assessment and the use of key performance indicators

Authors: Yefimenko, N., Boric, K., and Di Mauro G
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

The challenges and lessons learnt from conducting COVID-19 monitoring studies through VAC4EU: coordination and management perspective

Authors: Yefimenko, N., Weinrib, R., Boric, K., Riefolo, F., Jansen, M., Weibel, D.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Safety monitoring of COVID-19 vaccines in multiple European countries: initial results from the COVID-19 Vaccine Monitor (CVM).

Authors: Raethke, M., Luxi, N., Trifirò, G., Thurin, NH., Mentzer, D., De Clercq, E., Kovačić, B., Morton, K., Costa Alves, CM., Sonderlichová, S., Villalobos, F., Riefolo, F., van Hunsel, F., Sturkenboom, M.
Year: 2023
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: methods and results of the first study feasibility assessment

Authors: Ahmadizar, F., Fortuny, J., Cid-Royo, A... Boric, K., Yefimenko, N., Carreras, JJ., Urcheguia, A., Correcher-Martinez, E., Mira-Iglesias, A., Swart, KMA., van den Berg, JM., Overbeek, JA., Villalonos, F., Bissacco, CA., Newbern, C., Praet, N., Willame, C., Sturkenboom, M.
Year: 2023
DOI: 10.1002/pds.5687
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries

Authors: Weibel, D., De Luise, C., Elbers, R...Yefimenko, N. , Poblador-Plou, B., Marconi, E., Barbieri, E., Stona, L., Swart, KMA., Roy, D., Hyeraci, G., Bartolini, C., Lupattelli, A., Villalobos, F., Kendrick, K., Garg, R., Rubino, H., Eijkemans, R., Sturkenboom, M., Arana, A.
Year: 2023
DOI: 10.1002/pds.5687
Poster presented at the 39th ICPE Annual Meeting. August 25, 2023. Halifax, Canada

Rapid Safety Assessment of SARS-CoV-2 Vaccines in EU Member States using Electronic Health Care Data Sources (COVID Vaccine Monitor-CVM study): Final Study Report for WP3 (electronic health record data)

Authors: Durán, C. E., Schultze, A., Douglas, I., Bots, S., Belitser, S., Messina, D., Martin, I., Gini, R., Riefolo, F., Klungel, O., & Sturkenboom, M.
Year: 2023
DOI: https://zenodo.org/records/10093613

The impact of COVID-19 on population level drug utilisation of Alendronate in five European countries: an uninterrupted time series analysis

Authors: Tan, E. H., Robinson, D., Jödicke, A., Mosseveld, M., Bødkergaard, K., Reyes, C., Marconi, E., Lapi, F., Reinold, J., Verhamme, K., Pedersen, L., de Wilde, M., Far Ruiz, M., Aragòn, M., Grelaud, A., Lassalle, R., Riefolo, F., Yefimenko, N., Prieto-Alhambra, D., & Sanchez-Santos, M. T.
Year: 2023
Poster presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; May 2023. Barcelona, Spain

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Authors: Ahmadizar, F., Luxi, N., Raethke, M., Schmikli, S., Riefolo, F., Saraswati, P. W., Bucsa, C., Osman, A., Liddiard, M., Maques, F. B., Petrelli, G., Sonderlichová, S., Thurin, N. H., Villalobos, F., Trifirò, G., Sturkenboom, M., Moretti, U., Bellitto, C., Ciccimarra, F., … Mastropasqua, D.
Journal: Drug Safety
Year: 2023
DOI: 10.1007/S40264-023-01304-5

Covid-Vaccine-Monitor: a Cohort Event Monitoring Safety Study of COVID-19 Vaccines in Thirteen European Countries

Authors: Riefolo, F. , Raethke, M., Luxi, N., Ruijs, L., Giovanazzi, A., Schmitz, J., Mentser, D., Thurin, N., Miroservic-Skvrce, N., Liddiard, M., Schmikili, S., Klungel, O., Trifirò, G., Sturkenboom MCJM.
Year: 2022
DOI: 10.1007/s40264-022-01219-77

VAC4EU: a pan-European research network for collaborative post-authorization vaccine safety and benefit monitoring

Authors: Di Mauro, G., Gini, R., Mahey, P., Molero, E., Weibel, D., Sturkenboom MCJM.
Year: 2022
DOI: 10.1007/s40264-022-01219-7

VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in four European countries: study design and first results

Authors: Weibel, D., van den Bor, R., Elbers, R., Plana, E., Garcia de Albeniz, X., Weinrib, R., Yefimenko, N., Haugh, M., Poblador Plou, B., Bianchini, E., Barbieri, E., Stona, L., Swart-Polinder, Roy, D., Hyeraci, G., Bartolini, C., Lupattelli, A., Villalobos, F., de Luise, C., … Arana, A.
Year: 2022
DOI: 110.1002/pds.551
Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark

Conducting observational multi-country studies for regulatory decision making during COVID-19 pandemic: the strategic role of the scientific study manager

Authors: Yefimenko, N., Riefolo, F., Boric, K.,Di Mauro, G., Molero, E.
Year: 2022
DOI: 10.1002/pds.551

Covid-19 Vaccine Monitor: Interim Study Report for Cohort Event Monitoring of vaccinated persons

Authors: Luxi, N., Raethke, M., Ruijs, L., Schmikli, S., Riefolo, F. , Trifiro, G., Sturkenboom, MCJM.
Year: 2022
DOI: 10.1002/pds.5687

EU-PEARL: Changing the paradigm of clinical trials in Europe

Authors: Cash-Gibson, L., Pericàs, JM., Spiertz, C., van de Ketterij, E., Molero, E., Patalano, F., Kalra, D., Ussi, A., Van Dessel, A., Genescà, J.
Journal: European Journal of Public Health
Year: 2021
DOI: 10.1093/ckab165.657/6406328

Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory

Authors: tamm, T., Bott, N., Thwaites, R...Molero, E., Newson, R., Patalano, F., Prasser, F., Rose, M., Lindskov Sachs, M., Soderberg, J., Strammiello, V., van de Poll, L., Styliadou, M.
Journal: NEJM Catalyst Innovations in Care Delivery
Year: 2021
DOI: 10.1056/CAT.21.0146

Rational Design of Photochromic Analogues of Tricyclic Drugs

Authors: Riefolo, F., Sortino, R., Matera, C., Claro, E., Preda, B., Vitiello, S., Traserra, S., Jiménez, M., Gorostiza, P.
Journal: Journal of Medicinal Chemistry
Year: 2021
DOI: 10.1021/acs.jmedchem.1c00504

Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action

Authors: Cavaller-Bellaubi, M., Faulkner, S., Teixeira, B., Boudes, M., Molero, E., Brooke, N., McKeaveney, L., Southerton, J., Vicente, MJ., Bertelsen, N., García-Burgos, J., Pirard, V., Reid, K., Ferrer, E.
Journal: Therapeutic Innovation & Regulatory Science
Year: 2021
DOI: 10.1007/s43441-021-00282-z

Control of Brain State Transitions with a Photoswitchable Muscarinic Agonist

Authors: Barbero-Castillo, A., Riefolo, F., Matera, C., Caldas-Martínez, S., Mateos-Aparicio, P., Weinert, J.F., Garrido-Charles, A., Claro, E., Sanchez-Vives, M.V., Gorostiza P.
Journal: Advanced Science
Year: 2021
DOI: 10.1002/advs.202005027

Novel analgesic agents obtained by molecular hybridization of orthosteric and allosteric ligands

Authors: Matera, C., Flammini, L., Riefolo, F., Domenichini, G., De Amici, M., Barocelli, E., Dallanoce, C., Bertoni, S.
Year: 2020
DOI: 10.1016/j.ejphar.2020.173061

Optical Control of Cardiac Function with a Photoswitchable Muscarinic Agonist

Authors: Riefolo, F. , Matera, C., Garrido-Charles, A., Gomila, A. M. J., Sortino, R., Agnetta, L., Claro, E., Masgrau, R., Holzgrabe, U., Batlle, M., Decker, M., Guasch, E., Gorostiza, P. .
Journal: Journal of the American Chemical Society
Year: 2019
DOI: 10.1021/jacs.9b03505

Fluorination of Photoswitchable Muscarinic Agonists Tunes Receptor Pharmacology and Photochromic Properties

Authors: Agnetta, L., Bermudez, M., Riefolo, F., Matera, C., Claro, E., Messerer, R., Littmann, T., Wolber, G., Holzgrabe, U., Decker, M.
Journal: Journal of Medicinal Chemistry
Year: 2019
DOI: 10.1021/acs.jmedchem.8b01822

The European medical information framework: A novel ecosystem for sharing healthcare data across Europe

Authors: Lovestone, S., EMIF Consortium
Journal: Learn Health Systems
Year: 2019
DOI: 10.1002/lrh2.10214.

Real world evidence multi-database research in Europe; The EU-ADR Alliance

Authors: Yefimenko, N., Molero E., Prieto-Alhambra, D., Pedersen, L., Lapi, F. Verhamme, K, De Ridder, M., Rijnbeek, P., Giaquinto, C., van der Lei, J.
Year: 2019
Poster presentation at ISPE 2019

The EU-ADR Alliance: A federated collaborative framework for drug safety studies

Authors: Molero, E., Díaz, F., Sanz, J. L., Oliveira, G., Trifirò, A., Fourrier-Réglat, M., Molokhia, L., Pedersen, S., Boyer, L., Scotti, R., Gini, R., Herings, C., Giaquinto, M. I., Loza, G., Mazzaglia, J., van der Lei, M., Sturkenboom, M on behalf of the EU-ADR consortium
Journal: Journal of Medicinal Chemistry
Year: 2012
Poster presentation at ISPE 2012

Solving bottlenecks in data sharing in the life sciences

Authors: Dalgleish, R., Molero, E., Kidd, R., Jansen, M., Past, D., Robl, A., Mons, B., Diaz, C., Mons, A., Brookes, AJ.
Journal: Human Mutation
Year: 2012
DOI: 10.1002/humu.22123

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