European Perspectives

UBC - November 07, 2014
The centralised procedure, which came into operation in 1995, allows applicants to pursue a marketing authorisation that is valid throughout the EU. The European Medicines Agency (EMA) can take up to 210 days to review these new...
UBC - August 12, 2014
European Directive 2001/83/EC requires market authorisation holders to monitor the outcome of risk minimisation measures. Whilst the evaluation will take place after there has been adequate market uptake to the medicinal product,...
UBC - July 14, 2014
Manufacturers of all sizes can benefit from outsourcing pharmacovigilance activities. The expertise, systems and flexibility provided by a vendor can complement current activities or even provide an entire team without the need to...
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UBC - June 30, 2014
The increased use and importance of observational studies necessitates sponsor evaluation of standard operating procedures for clinical trials. Often the focus of that evaluation is on methodology, structure, and resulting evidence,...
UBC - June 11, 2014
When you ask UBC employees why they love what they do, their answers speak to the heart of what makes UBC great. Here are the top 8 reasons why UBC employees come to work every day. Developing life-saving medications The clinical...
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