Risk Management & Pharmacovigilance

UBC - January 08, 2015
This year is shaping up to be another exciting one for the UBC team. With nearly 50 conferences already booked for the year, our thought leaders are looking forward to learning, networking, and presenting their work at a host of...
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 - October 14, 2014
When you think about outsourcing, what keeps you up at night? The next big RFP? A new online bidding tool? In our fast-paced industry, it’s easy to focus on the next task at hand. When it comes to outsourcing, focusing on the details...
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Amal Souttou, Safety Physician, Pharmacovigilance - September 23, 2014
As social media use increases, so do the number of disease and therapeutic resource forums and communication threads. At the same time, pharmaceutical business is moving faster and vigilance legislation is getting tighter to regulate...
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,...

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