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

Elizabeth Murray; Rodney McAdam; Moira T. Burke

doi:10.1108/09526860410563195

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

Elizabeth Murray, Rodney McAdam, Moira T. Burke

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

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.

Original language	English
Pages (from-to)	389-393
Number of pages	5
Journal	International Journal of Health Care Quality Assurance
Volume	17
Issue number	7
DOIs	https://doi.org/10.1108/09526860410563195
Publication status	Published - 2004

Keywords

Clinical medicine
European union information
Organizational change
Pharmaceuticals industry
Research organizations

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10.1108/09526860410563195

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