Regulatory Approaches for a Retrospective Multicentre Multinational Study on Data: An Example Conducted in France, Ireland and England

Candice Houg, Candice Houg, Thomas Lihoreau, Thomas Lihoreau, Martina Hennessy, Kristina Mouyabi, Rachel Benamore, Jean Palussiere, Julien Behr, Lionel Pazart, Lionel Pazart

2022

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.

Paper Citation

in Harvard Style

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 - Volume 1: ClinMed, ISBN 978-989-758-552-4, pages 289-293. DOI: 10.5220/0010971800003123

in Bibtex Style

@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 - Volume 1: ClinMed,},
year={2022},
pages={289-293},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010971800003123},
isbn={978-989-758-552-4},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: 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
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