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A critique of emerging European legislation in the pharmaceutical industry: a clinical trials analysis

Elizabeth Murray (Biokinetic Europe Ltd, UK)
Rodney McAdam (Professor in Innovation Management, University of Ulster, School of Business, Organisation and Management, Jordanstown, Belfast, UK)
Moira T. Burke (Biokinetic Europe Ltd, UK)

International Journal of Health Care Quality Assurance

ISSN: 0952-6862

Article publication date: 1 December 2004

Abstract

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.

Keywords

Citation

Murray, E., McAdam, R. and Burke, M.T. (2004), "A critique of emerging European legislation in the pharmaceutical industry: a clinical trials analysis", International Journal of Health Care Quality Assurance, Vol. 17 No. 7, pp. 389-393. https://doi.org/10.1108/09526860410563195

Publisher

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Emerald Group Publishing Limited

Copyright © 2004, Emerald Group Publishing Limited