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Authors: Candice Houg 1 ; 2 ; Thomas Lihoreau 1 ; 2 ; Martina Hennessy 3 ; Kristina Mouyabi 1 ; Rachel Benamore 4 ; Jean Palussiere 5 ; Julien Behr 6 and Lionel Pazart 1 ; 2

Affiliations: 1 Centre Hospitalier Universitaire de Besançon, Centre d'Investigation Clinique, INSERM CIC 1431, 25030, Besançon, France ; 2 Tech4Health network - FCRIN, France ; 3 Wellcome-HRB Clinical Research Facility, St James’s Hospital and School of Medicine Trinity College Dublin, Dublin, Ireland ; 4 Department of Radiology, Oxford University Hospital Trust, Oxford, U.K. ; 5 Department of Interventional Radiology, Bergonie Institute, Bordeaux, France ; 6 Department of Radiology, University Hospital of Besançon, Besançon, France

Keyword(s): Retrospective Study, Study on Data, Regulatory Approach.

Abstract: Retrospective studies are studies that easily provide data on a population. As the data are already available in the medical records, the collection and analysis of the results is faster. These studies are particularly valuable in the post-marketing clinical follow-up of medical devices. They allow manufacturers to easily and proactively obtain safety and performance data. The regulatory procedures associated with this type of study also appear to be much less burdensome than a prospective study. We propose to illustrate the procedures through a multinational retrospective study conducted in France, England and Ireland.

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Paper citation in several formats:
Houg, C.; Lihoreau, T.; Hennessy, M.; Mouyabi, K.; Benamore, R.; Palussiere, J.; Behr, J. and Pazart, L. (2022). Regulatory Approaches for a Retrospective Multicentre Multinational Study on Data: An Example Conducted in France, Ireland and England. In Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed; ISBN 978-989-758-552-4; ISSN 2184-4305, SciTePress, pages 289-293. DOI: 10.5220/0010971800003123

@conference{clinmed22,
author={Candice Houg. and Thomas Lihoreau. and Martina Hennessy. and Kristina Mouyabi. and Rachel Benamore. and Jean Palussiere. and Julien Behr. and Lionel Pazart.},
title={Regulatory Approaches for a Retrospective Multicentre Multinational Study on Data: An Example Conducted in France, Ireland and England},
booktitle={Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2022},
pages={289-293},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010971800003123},
isbn={978-989-758-552-4},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed
TI - Regulatory Approaches for a Retrospective Multicentre Multinational Study on Data: An Example Conducted in France, Ireland and England
SN - 978-989-758-552-4
IS - 2184-4305
AU - Houg, C.
AU - Lihoreau, T.
AU - Hennessy, M.
AU - Mouyabi, K.
AU - Benamore, R.
AU - Palussiere, J.
AU - Behr, J.
AU - Pazart, L.
PY - 2022
SP - 289
EP - 293
DO - 10.5220/0010971800003123
PB - SciTePress