Risk Management & Pharmacovigilance

UBC - April 08, 2014
Creating a REMS assessment report requires a high-functioning, coordinated team effort, often involving numerous departments and external vendors. UBC’s REMS experience, including our work with REMS assessment reports, has played a...
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UBC has experience with more than 100 REMS programs
Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management - March 07, 2014
Without a strict set of safety guidelines in place, some much-needed therapies would not be available for patients who need them most. Currently, 66 drugs on the market require a Risk Evaluation and Mitigation Strategy (REMS) to...
UBC - March 06, 2014
Recent regulatory updates to EMA-mandated PASS requirements and FDA-mandated Post-Marketing Requirements (PMRs) have changed the way safety research is performed. New themes are also emerging for late stage development. As industry...
UBC - February 06, 2014
The convergence of payer and regulator evidence requirements warrants a strategic evidence generation plan and a mindful orchestration of peri and postapproval real-world studies.  Study designs resulting in a diverse array of...
Janine Collins, MBBS, LLM, Senior Director, European Risk Management - January 24, 2014
This week, I had the privilege of chairing the 4th Annual Pharmacovigilance & Risk Management Strategies Conference in Amsterdam, Netherlands.  This event struck me as unique because the conversations were not theoretical; we...

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