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Home - Analysis
ANALYSIS
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EXPERT VIEW
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EDITORIALS
UK Shuffle Will Undermine Stem Cell Progress
14 September 2010
Karen Finn
Karen Finn argues that while proposals by the Department of Health aim to reduce the number of health arm's-length bodies and deliver significant cost savings, they might have serious consequences for stem cell advances on the global front. At first ...
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FEATURES
EMA seeks out ATMP manufacturers in advance of approval deadlines
18 February 2011
Maureen Kenny reports on efforts by the European Medicines Agency to ensure manufacturers of advanced therapies won't be caught out by approaching ...
The revision of the EU medical device directives revision and variations in national laws
12 January 2011
How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done ...
ISO 14644: cleanroom classification and monitoring changes ahead
10 January 2011
Tony Harrison explains why the key revisions in the draft of international standard ISO 14644 will affect GMP-compliant companies. Parts 1 and 2 of ...
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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 EspaƱola del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
PEOPLE
AdvaMedDx names associate vice president
Policy analyst Tharini Sathiamoorthy has been named associate vice president of AdvaMedDx, the diagnostics arm of US medtech industry association AdvaMed . Ms Sathiamoorthy was previously a senior associate in the health policy practice at public ...
Michael Carome joins Public Citizen's Health Research Group
Michael Carome, an internationally recognised expert on the protection of human research subjects, has been appointed deputy director of the Health Research Group of the US consumer advocacy organisation Public Citizen . Prior to joining HRG, Dr ...
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US