Nicolette Dent

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Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state "GLP is a quality system concerned with the organisational process(More)
This article sets out to explore whether or not the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are exportable outside the European Union (EU). It is not a question of whether the Guidelines per se are exportable but rather can studies outside the EU be performed to the same, or a better standard? It is well(More)
As a Scientific Consultant in the area of Good Laboratory Practice and Good Clinical Practice the author has been involved with Quality Assurance (QA) for 18 years and fells the time has come for Industry to explore a better way to utilize the many talents that the QA professional has achieved. They have a wealth of expertise and should become more involved(More)
Introduction As part of a statewide effort to enhance surveillance for Aedes spp. mosquitoes (1,2) the Office of Border Health (OBH) took the lead in providing technical assistance on surveillance in counties bordering Mexico. In 2016, OBH sought ways to enhance surveillance in a wider geographic area. Trap locations closer to the border were established as(More)
A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical(More)