Yeimenko, N., Palà, E., Molero, E., Riefolo, F., Di Mauro, G. (2024) Unlocking Real-World Evidence in post marketing surveillance: The Critical Role of Scientific Management.

White paper available through this link. 

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. (2024) (093) Cohort event monitoring of COVID-19 vaccine safety using patient-reported outcomes in lactating women. Poster presented at the 40th Annual Meeting of the International Society of Pharmacoepidemiology. August 26, 2024. Berlin, Germany.  

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. (2024) What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study. Drug Saf. June 2024.

Available from: https://doi.org/10.1007/s40264-024-01449-x

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. (2024). A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases. Vaccine, Volume 42, Issue 12, Pages 3039-3048.

Available from: https://doi.org/10.1016/j.vaccine.2024.03.043

Raethke, M., van Hunsel, F., Luxi, N., Lieber, T., Bellitto, C., Mulder, E., Ciccimarra, F., Riefolo, F., et al. (2024). Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study. Vaccine, Volume 42, Issue 9, 2024, Pages 2357-2369.

Available from: https://doi.org/10.1016/j.vaccine.2024.03.001

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. (2024). Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study. Vaccines, 12, 241.

Available from: https://doi.org/10.3390/vaccines12030241

Koenig, F., Spiertz, C., Millar, D., Rodríguez-Navarro, S., Machín, N., Dessel, A. van, Genescà, J., Pericàs, J. M., & Posch, M. (2023). Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL. eClinicalMedicine, December 2023.

Available from: https://doi.org/10.1016/j.eclinm.2023.102384 

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. (2023). Effectiveness of homologous/heterologous booster COVID-19 vaccination schedules against severe illness in general population and clinical subgroups in three European countries. Vaccine, 41(47), 7007–7018.

Available from: https://doi.org/10.1016/j.vaccine.2023.10.011

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. (2023). Real-world-evidence on different COVID-19 vaccines combinations’ effectiveness in six electronic healthcare data sources from four pan-European countries. Poster presented at the 17th Vaccine Congress; 24-27 September 2023. Glasgow, Scotland.

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. (2023). 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. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

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. (2023). Incidence of COVID-19 Disease Severity in a Cohort of 4.4 Million Italian and Spanish Children from 6 Healthcare Databases. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

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. (2023). Safety of COVID-19 Vaccines Among People  with Prior History of SARS-Cov-2 Infection:  Results from the COVID-Vaccine-Monitor Cohort  Event Monitoring. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

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. (2023). Representation of Study Scripts to Improve Transparency and Efficiency in Multidatabase Distributed Vaccine Studies. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

Yefimenko, N., Boric, K., and  Di Mauro G. (2023). Quality compliance while conducting NIS studies: critical success factors assessment and the use of key performance indicators. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. Access poster Access poster here.

Yefimenko, N., Weinrib, R., Boric, K., Riefolo, F., Jansen, M., Weibel, D. (2023). The challenges and lessons learnt from conducting COVID-19 monitoring studies through VAC4EU: coordination and management perspective. P-395. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

Available from: https://10.1002/pds.5687

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 (2023). Safety monitoring of COVID-19 vaccines in multiple European countries: initial results from the COVID-19 Vaccine Monitor (CVM). Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. Access poster here.

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. (2023). Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: methods and results of the first study feasibility assessment.  P-415. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. 

Available from: https://doi. 10.1002/pds.5687

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. (2023) Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries.P-384. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada.

Available from: https://doi.10.1002/pds.5687

Durán, C. E., Schultze, A., Douglas, I., Bots, S., Belitser, S., Messina, D., Martin, I., Gini, R., Riefolo, F., Klungel, O., & Sturkenboom, M. (2023). Covid-Vaccine-Monitor Final Study Report for WP3 (electronic health record data) Deliverable 4.2-May 2023. Access poster here: 

Available from: https://doi.10.5281/zenodo.8280174. 

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. (2023). The impact of COVID-19 on population level drug utilisation of Alendronate in five European countries: an uninterrupted time series analysis. Poster presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; May 2023. Barcelona, Spain. Poster available here.

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. (2023). Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials. Drug Safety, 46(6), 575–585.

Available from: https://doi.org/10.1007/S40264-023-01304-5

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. (2022). Covid-Vaccine-Monitor: a Cohort Event Monitoring Safety Study of COVID-19 Vaccines in Thirteen European Countries. Poster presentation – P092. Poster presented at the 21st ISoP Annual Meeting, September 2022. Verona (Italy).

Available from: https://doi.org/10.1007/s40264-022-01219-7

Di Mauro, G., Gini, R., Mahey, P.,  Molero, E., Weibel, D., Sturkenboom MCJM. (2022). VAC4EU: a pan-European research network for collaborative post-authorization vaccine safety and benefit monitoring. Poster presentation – P245 

Available from: https://doi.org/10.1007/s40264-022-01219-7

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. (2022). VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in four European countries: study design and first results. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8.

Available from: https://doi.org/10.1002/pds.551

Yefimenko, N., Riefolo, F.,  Boric, K.,Di Mauro, G., Molero, E. (2022). Conducting observational multi-country studies for regulatory decision making during COVID-19 pandemic: the strategic role of the scientific study manager. (2022) Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8.

Available from: https://doi.org/10.1002/pds.551

Luxi, N., Raethke, M., Ruijs, L., Schmikli, S., Riefolo, F., Trifiro, G., Sturkenboom, MCJM. (2022). Covid-19 Vaccine Monitor: Interim Study Report for Cohort Event Monitoring of vaccinated persons. 

Available from Zenodo: DOI 10.5281/zenodo.6629550.

Cash-Gibson, L., Pericàs, JM., Spiertz, C., van de Ketterij, E.,Molero, E., Patalano, F., Kalra, D., Ussi, A., Van Dessel, A., Genescà, J. (2021) EU-PEARL: Changing the paradigm of clinical trials in Europe, European Journal of Public Health, Volume 31, Issue Supplement_3, October 2021.

Available from: https://doi.10.1093/ckab165.657/6406328.

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. (2021) Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory, NEJM Catalyst Innovations in Care Delivery, June 2021.

Available from: https://doi.10.1056/CAT.21.0146

Riefolo, F., Sortino, R., Matera, C., Claro, E., Preda, B., Vitiello, S., Traserra, S., Jiménez, M., Gorostiza, P. (2021) Rational Design of Photochromic Analogues of Tricyclic Drugs in Journal of Medicinal Chemistry 2021 64 (13), 9259-9270, June 2021.

Available from: https://doi.10.1021/acs.jmedchem.1c00504

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. (2021) Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action in Therapeutic Innovation & Regulatory Science (2021), May 2021.

Available from: https://doi.10.1007/s43441-021-00282-z

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. (2021) Control of Brain State Transitions with a Photoswitchable Muscarinic Agonist in Advanced Science, May 2021.

Available from: https://doi.10.1002/advs.202005027

Matera, C., Flammini, L., Riefolo, F., Domenichini, G., De Amici, M., Barocelli, E., Dallanoce, C., Bertoni, S. (2020) Novel analgesic agents obtained by molecular hybridization of orthosteric and allosteric ligands in European Journal of Pharmacology Volume 876, March 2020.

Available from: https://doi.10.1016/j.ejphar.2020.173061

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. (2019) Optical Control of Cardiac Function with a Photoswitchable Muscarinic Agonist in Journal of the American Chemical Society 2019 141 (18), 7628-7636, April 2019.

Available from: https://doi.10.1021/jacs.9b03505

Agnetta, L., Bermudez, M., Riefolo, F., Matera, C., Claro, E., Messerer, R., Littmann, T., Wolber, G., Holzgrabe, U., Decker, M. (2019) Fluorination of Photoswitchable Muscarinic Agonists Tunes Receptor Pharmacology and Photochromic Properties in Journal of Medicinal Chemistry 2019 62 (6), 3009-3020, March 2019.

Available from: https://doi.10.1021/acs.jmedchem.8b01822

Lovestone, S., EMIF Consortium. The European medical information framework: A novel ecosystem for sharing healthcare data across Europe. Learn Health Sys. 2019; e10214.   

Available from: https://doi.10.1002/lrh2.10214.

Yefimenko, N., Molero E., Prieto-Alhambra, D., Pedersen, L., Lapi, F. Verhamme, K, De Ridder, M., Rijnbeek, P., Giaquinto, C., van der Lei, J.  (2019). Real world evidence multi-database research in Europe; The EU-ADR Alliance. Poster presentation at ISPE 2019.

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 (2012). The EU-ADR Alliance: A federated collaborative framework for drug safety studies. Poster presentation at ISPE 2012.

Dalgleish, R.,Molero, E., Kidd, R., Jansen, M., Past, D., Robl, A., Mons, B., Diaz, C., Mons, A., Brookes, AJ. (2012) Solving bottlenecks in data sharing in the life sciences. Human Mutation; 33: 1494-1496