Risk Management & Pharmacovigilance

UBC - March 06, 2013
Recently we announced the expansion of our Risk Management Services in Europe.  Janine Collins, M.D., has joined UBC and is leading our European Risk Management activities and Medical Safety.  As we knew she would, she’s hit...
Heather Gagnier, MT(ASCP), Executive Director, Commercial Strategy & Opportunity Development - February 01, 2013
As the sixth year of the REMS era begins, FDA’s use of Risk Evaluation and Mitigation Strategies (REMS) continues to decline.  Since 2007 when the FDA Amendments Act (FDAAA) went into effect, there have been more than 200 REMS...
UBC - January 23, 2013
At this week's exl Risk Evaluation & Mitigation Strategies Summit, UBC's Heather Gagnier and Lee Ann Steadman will present, Balancing Regulatory and Commercial Requirements in Complex REMS Programs.  Complex REMS,...
UBC - October 30, 2012
We’ve heard from pharmaceutical manufacturer sponsors that the thought of having the FDA mandate a Single Shared System REMS on their product gives them nightmares.   Well, we’re here to tell you, there’s no need to lose...

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