PUBLICATIONS & REPORTS

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

Publications & Reports

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

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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.
Repository: Zenodo
Year: 2024
DOI: 10.5281/zenodo.13384860

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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
Link: http://teamitresearch.com/wp-content/uploads/2024/08/Teamit-White-Paper-Final.pdf

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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., Bellitto, C., Raethke, M., van Hunsel, F., Lieber, T., Mulder, E., 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

Poster presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology. August 26, 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., Bellitto, C., Raethke, M., van Hunsel, F., Lieber, T., Mulder, E., 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

Poster presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology. August 27, 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., Ryan, O., Vaz, T., Aguado, J., Marsal, J., de Albéniz Martínez, X., Weinrib, R., Yefimenko, N., Palà, E., Poblador-Plou, B., Gimeno-Miguel, A., Santos-Mejias, A., Marconi, E., Barbieri, E., Stona, L., Lysen, T., Roy, D., Hyeraci, G., Girardi, A., Lupattelli, A., Desalegn, A., Villalobos, F., Bissacco, C., Kendrick, K., Garg, R., Rubino, H., Sturkenboom, M., Arana, A.
Year: 2024

Poster presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology. August 27, 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., Plana, E., Weinrub, R., Garcia, Raquel., 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

Poster presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology. August 27, 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., L’Abbate, L., Raethke, M., van Hunsel, F., Lieber, T., Mulder, E., 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

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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
Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC11102056/

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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., Bots, S., Belitser, S., José Carreras-Martínez, J., Correcher-Martinez, E., Urchueguía-Fornes, A., Martín-Pérez, M., García-Poza, P., Villalobos, F., Pallejà-Millán, M., Alberto Bissacco, C., Segundo, E., Souverein, P., Riefolo, F. , Durán, C. E., Gini, R., Sturkenboom, M., … Douglas, I.
Journal: Vaccine
Year: 2024
DOI: 10.1016/j.vaccine.2024.03.043

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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

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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

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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

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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., Messina, D., Elbers, R., Brink-Kwakkel, D., 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

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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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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
Link: https://teamitresearch.com/wp-content/uploads/2023/09/20230728_v3_ICPE23poster_QMSTeamit.pdf

Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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 International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). 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., Plana, E., Weinrib, R., Garcia Esteban, R., 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 Conference; 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., van den Bor, R., Martin, I., Cid-Royo, A., Plana, E., Garcia de Albeniz Martinez, X., Weinrib, 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
Link: 10.1002/pds.5687

Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada.

COVID-Vaccine-Monitor Final Study Report for WP3

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: 10.5281/zenodo.8280174

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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

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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

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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

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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

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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
Link: 10.1002/pds.5687

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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
Link: 10.1093/ckab165.657/6406328

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

Authors: Stamm, T., Bott, N., Thwaites, R., Mosor, E., Andrews, MR., Borgdorff, J., Cossio-Gil, Y., de Portu, S., Ferrante, M., Fischer, F., Hameed, F., Hazelzet, J., Hopkins, D., Kalra, D., Metcalfe, T., 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

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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

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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
Link: 10.1007/s43441-021-00282-z

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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

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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

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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
Link: 10.1021/jacs.9b03505

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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

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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.

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