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Welcome: IBI01 - Circulation
03 September 2010

The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

03 September 2010

The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

02 September 2010

The US Food and Drug Administration has become more conservative in allowing evidence from non-inferiority clinical trials when considering approval of new drugs, the Government Accountability Office has found 1 . Non-inferiority trials are ...

23 July 2010

Top level regulators in Europe have rejected a recommendation that the European Medicines Agency create a dedicated sub-committee to deal with the current overload of applications for generic and biosimilar drugs that are awaiting review via its ...

23 July 2010

The US Food and Drug Administration is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated with its current user fee programme, PDUFA IV, can ...

QSE
21 June 2010

Brenda Percy explains why quality should be a part of change management throughout the whole product life-cycle and how to achieve this. Change is often said to be the only constant. This rings true particularly within the pharmaceutical industry, ...

11 May 2010

A US congressional committee has begun an investigation into the circumstances surrounding the most recent voluntary recall by McNeil Consumer Healthcare of more than 40 widely used over-the-counter paediatric medicines, including Children?s and ...

 
29 January 2010
Ashley Yeo
The UK government and the life science industries have marked a year of action and progress for the Office for Life Sciences (OLS) with the release of a final report on its work to date and future plans. A lot has been written about the unique ...
 
09 June 2009
Karen Finn
Nearly a year has elapsed since companies seeking marketing authorisations in the European Union were required to begin submitting paediatric ...
 
21 June 2010
Brenda Percy explains why quality should be a part of change management throughout the whole product life-cycle and how to achieve this. Change is ...
21 June 2010
Legislation affecting the sector was high on the agenda at the Spanish pharmaceutical industry association?s annual symposium in Madrid. Maria Luisa ...
02 November 2009
Peter Charlish looks at the regulation of ?e-cigarettes? and finds they can be drugs, devices, neither or both. Unless it is very tightly drawn up, ...
 
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
07 October 2009
Please give details of the major acts and directives governing trademarks. Benelux Convention on Intellectual Property: Convention Benelux en matière ...
 
RAJ Pharma News Roundup, 11 December 2009
11 December 2009
 
 
EVENTS
October 4th, 2010
London, UK
October 19th, 2010
Barcelona, Spain
October 20th, 2010
Barcelona, Spain
   
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