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Premarketing Regulation - QSE
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EXPERT VIEW
Danes urge austerity as EU health issues loom large
11 January 2012
Ian Schofield
Much has been made of Denmark's announcement that its presidency of the EU Council of Ministers will be an austere one financially, in the spirit of ...
INTERVIEW
The EDQM: ensuring drug quality in the face of globalisation
25 October 2010
Neena Brizmohun
Dr Susanne Keitel, director of the European Directorate for the Quality of Medicines & HealthCare, tells Neena Brizmohun how the European ...
LATEST FEATURES
Developing a common benefit-risk assessment methodology for medicines - a progress report
09 December 2011
Stuart Walker, Neil McAuslane and Lawrence Liberti report from a high-level workshop on the current status of the various programmes to develop a ...
Poor manufacturing practices and the problem of substandard medicines in sub-Sahara Africa
11 November 2011
Ndjamawe Bah-Traore, Ludwig Hoellein, Johannes Baeumert, Harald G Schweim and Ulrike Holzgrabe describe the results of their survey on the ...
Warning letters: causes and prevention for medtech and pharma firms
12 October 2011
With warning letters and other regulatory action by the US Food and Drug Administration hitting an all-time high, it's a good time to reflect and ask ...
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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 Espaņola del Medicamento, the ...
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MULTIMEDIA
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
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