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Regulatory Region - Europe
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EXPERT VIEW
Assessing the size of the US recall issue
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
INTERVIEW
Notified body TÜV PS calls for competent authority action in Europe
23 July 2010
Amanda Maxwell
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory ...
LATEST FEATURES
Supplementary protection certificates: is a new era beckoning for combination drugs in the EU?
28 July 2011
Michael Pears and Mike Snodin consider the opinion of an Advocate General of the Court of Justice of the EU on granting supplementary protection certificates for combination medicines. In a non-binding opinion issued on 13 July, Advocate General ...
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 approval deadlines. At least 20 advanced therapy medicinal products that are currently on the market ...
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 approval deadlines. At least 20 advanced therapy medicinal products that are currently on the market ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Pharma) - 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 ...
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 ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
PEOPLE
Pharmacist takes the helm of Spanish regulator
Belén Crespo Sánchez-Eznarriaga has been appointed director of the Spanish healthcare products regulatory agency, the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) 1 . Ms Crespo replaces Cristina Avendaño, who had held the post ...
Pharmacist takes the helm of Spain's pharma regulator
Belén Crespo Sánchez-Eznarriaga has been appointed director of the Spanish healthcare products regulatory agency AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) 1 . She replaces Cristina Avendaño, who had held the post since 2006. Ms ...
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