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Regulatory Region - International
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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
European generics industry throws its weight behind IMPACT
07 April 2010
Faraz Kermani
The emergence of counterfeit medicines in the European Union and indeed globally is a serious problem for the pharmaceutical industry. Generally ...
LATEST FEATURES
What the International Medical Device Regulators Forum can do to re-energise efforts towards global regulatory harmonisation
27 January 2012
Gabriel Adusei explains how the IMDRF can build on the achievements of its predecessor, the Global Harmonization Task Force. As the International Medical Device Regulators Forum gears up for its inaugural meeting in Singapore at the end of February ...
Tackling medical software regulation
09 November 2011
Nicole Denjoy reports from a high-level conference on global developments for regulating medical device software. Standards are essential tools to support efficient regulation in all fields, no less so than in the medical technology space where ...
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 what we can learn from the mistakes of others, says Martin Lush . From the moment a company ...
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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
Saudi FDA's senior device official to head AHWP
The Asian Harmonization Working Party has elected as its new chairman the Saudi Food and Drug Authority 's vice president for medical device affairs, ...
TOPRA selects new president
Pfizer's Zubair Hussain has been elected as the new president of The Organisation for Professionals in Regulatory Affairs, a global not-for-profit ...
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