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Premarketing Regulation - R & D
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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
Optimism in the UK biosciences sector
16 December 2010
Karen Finn
BioIndustry Association chief executive Nigel Gaymond and head of regulatory affairs Christiane Abouzeid tell Karen Finn why they believe the UK ...
LATEST FEATURES
The EU orphan drug regulation: sink or swim?
14 January 2011
Ian Schofield considers the impact of the EU regulation for drugs for rare diseases. The EU's orphan drug regulation has been in force for just over ...
Optimism in the UK biosciences sector
16 December 2010
BioIndustry Association chief executive Nigel Gaymond and head of regulatory affairs Christiane Abouzeid tell Karen Finn why they believe the UK ...
Biosimilars: what US regulators might learn from others
13 December 2010
As the US Food and Drug Administration works to implement an approval pathway for biosimilars, Erika Lietzan and Emily Alexander look at how the ...
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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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