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Premarketing Regulation - Clinical Trials
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EXPERT VIEW
In praise of the CE marking, but medtech's worst fear is still alive
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
INTERVIEW
EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
30 July 2010
Amanda Maxwell
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
LATEST FEATURES
EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
30 July 2010
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
Understanding the US Programme for Bioresearch Monitoring
12 March 2010
Following the pledge by the Food and Drug Administration to step up efforts regarding its programme for ensuring the validity of the scientific data ...
Detecting Fraud and Misconduct in Clinical Research
11 March 2010
Michael R Hamrell tells sponsors and their trial monitors how to spot misconduct by clinical investigators and how to prevent it in the first ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, July 2010
19 July 2010
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