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Regulatory Region - International
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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 . ...
LATEST FEATURES
The challenges of achieving and maintaining inspection readiness
21 June 2011
Maria Cianciotto outlines how companies can ensure they are prepared for inspections at all times. A cost-centre, a roadblock, a speed bump on the road to success. As regulatory professionals, we've all heard these types of descriptions when talking ...
Refining the benefit-risk framework for assessing medicines: valuing and weighting the parameters
23 February 2011
Stuart Walker, James Neil McAuslane and Lawrence Liberti report on progress by regulators and industry on the development of a common benefit-risk assessment framework. A recent survey of drug companies on nearly 40 scenarios that may influence ...
Updating package inserts: the barriers to timely implementation
18 February 2011
Wenhong Li and Allan Johansen describe the hurdles drug companies might face in implementing updates to their product package inserts in a timely fashion. There are lots of grey areas regarding the time frames within which pharmaceutical companies ...
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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
Appointments II June 09
The European Medicines Agency has appointed Fergus Sweeney head of its Inspections Sector. Dr Sweeney joined the Inspections Sector in 1999. He is ...
Appointments I June 09
Kathleen Sebelius has been sworn in as secretary of the Department of Health and Human Services , following confirmation by the US Senate . Ms ...
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