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dc.contributor.advisorCormican, Kathryn
dc.contributor.authorMasterson, Fiona
dc.date.accessioned2016-02-09T16:37:53Z
dc.date.issued2015-09-30
dc.identifier.urihttp://hdl.handle.net/10379/5542
dc.description.abstractDrug/device combination products play a vital role in diagnosis and treatment of a wide range of disorders, including chronic disorders such as heart disease, cancer, respiratory disease, and diabetes. Doctors consider them a vital part of healthcare. The market for these products is growing. They include and combine products that originate in the pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors. Thus they draw on different conventions and face complex regulatory processes. No single regulatory framework has prevailed for these products and obtaining timely regulatory approval has proven challenging. However, research on these processes is scarce and the experience of life sciences companies bringing them to market remains poorly understood. This thesis enters this gap, offering insight into the experiences of those involved in obtaining regulatory approval of drug/device combination products in the European Union and the United States, and providing a conceptual model which life sciences companies can use when seeking regulatory approval for drug/device combination products.en_IE
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 Ireland
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/3.0/ie/
dc.subjectMedical device regulationen_IE
dc.subjectDrug regulationen_IE
dc.subjectDrug/device combination producten_IE
dc.subjectRegulatory Frameworksen_IE
dc.subjectRegulatory approvalen_IE
dc.subjectMarketing authorisationen_IE
dc.subjectRegulatory frameworksen_IE
dc.subjectMechanical engineeringen_IE
dc.titleFactors that facilitate regulatory approval for drug/device combination products in the European Union and United States of America: a mixed method study of industry viewsen_IE
dc.typeThesisen_IE
dc.contributor.funderCollege of Engineering and Informaticsen_IE
dc.local.noteThe regulatory environment is one of the key factors in successfully bringing an innovative medical product, like a drug/device combination product, to market. This thesis offers insight into the experiences of those involved in obtaining regulatory approval of drug/device combination products in the EU and the US.en_IE
dc.description.embargo2020-02-05
dc.local.finalYesen_IE
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Attribution-NonCommercial-NoDerivs 3.0 Ireland
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivs 3.0 Ireland