Risk Management & Pharmacovigilance

Joe Devine, Senior Director, Business Development - August 06, 2013
In the gambling world, the number seven is often viewed as lucky, but luck won’t help you prepare for your product’s ongoing safety needs.  So, we’ve put together a solid list of seven key questions you should be asking: 1....
UBC is participating in FDA meeting on Standardizing and Evaluating REMS
UBC - July 25, 2013
This week the Food and Drug Administration (FDA) is holding a meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) to obtain input on issues and challenges associated with the standardization and...
Tagged in:
UBC is a leader in creating customized risk minimization strategies
UBC - July 16, 2013
Pharmaceutical manufacturers understand that systems supporting approval and marketing for their products must be designed and implemented with a global outlook.   That’s easier said than done, taking into account the...
, Executive Director & Principal Scientific Consultant, Value Demonstration - May 07, 2013
Traditionally, chart review studies have been employed to evaluate burden of illness and patterns of care, but, increasingly, this methodology is being applied to meet marketing authorization and risk management data requirements...
UBC - April 29, 2013
When developing a European Risk Minimization program, one size really doesn’t fit all.  Manufacturers must consider that healthcare practices vary across Europe, leading to challenges in the implementation of risk minimization...

Pages