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Regulatory Region - Europe
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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 the times. The Danish government, which took over the presidency from Poland on 1 January, has set ...
INTERVIEW
Time for life science companies to step forward and adopt GxP cloud computing
08 December 2011
Maureen Kenny
Developing innovative products is the raison d?ętre of the world?s life science companies. Traditionally, however, such companies are hesitant when ...
LATEST FEATURES
Lessons to be learned courtesy of PIP
23 January 2012
Jeremy Tinkler considers who and what is to blame in the sub-standard breast implants affair and what can be done to close any regulatory loopholes. Once the political stakes have been raised, the parties in the firing line lose no time in ...
Advanced Therapies: is the EU regulatory approach putting a brake on development?
23 January 2012
The European Medicines Agency 's Committee for Advanced Therapies has put considerable effort into developing guidelines to explain how it operates. But has the CAT's apparent success in achieving its goals resulted in a labyrinth of guidance so ...
Fit for life: Bringing EU data protection into the 21st century for pharma and medtech
20 January 2012
Eduardo Ustaran, Phil Lee and Alison Dennis discuss the European Commission's forthcoming proposals to overhaul data privacy rules and explain how the new regime, if enacted into law, will affect pharmaceutical and medical device ...
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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
PEOPLE
Andreas Pott appointed as EMA deputy executive director
The European Medicines Agency has appointed Andreas Pott as its deputy executive director 1 . Mr Pott's appointment, which is now effective, follows 11 months of service as the EMA's acting executive director, prior to the Italian Medicines Agency's ...
French industry association, Snitem, names new director general
Eric Le Roy has been named the new director general of the French medtech industry association, Snitem . He succeeds Odile Corbin, who led the association for some 11 years and has helped the industry establish its voice within key decision-making ...
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