Risk Management & Pharmacovigilance

Expanded Access Programs EAP - UBC
UBC - June 04, 2015
Mapping a patient’s journey through an Expanded Access Program (EAP) requires multi-dimensional perspective and foresight. At the outset of a program, consideration must be given to the patient experience continuum starting with...
UBC - June 02, 2015
Development of specialty therapies is on the rise, especially for rare diseases, fueling an increase in patient awareness and advocacy. More often manufacturers are being asked to implement Expanded Access Programs (EAPs) while...
REMS Assessment Report - DIA tutorial - UBC
UBC - May 28, 2015
Creating a REMS assessment report requires a high-functioning, coordinated team effort, often involving numerous departments and external vendors. UBC’s REMS experts have designed, implemented, and/or evaluated more than 100 RiskMAPS...
Unique oncology solutions UBC
Don A. Gabriel, MD, PhD, Sr. Director, Medical Oncology & Scientific Strategy - May 21, 2015
UBC works with life science companies to help them develop a drug, take it through commercialization, and demonstrate its post-launch value and safety. UBC has extensive oncology experience in Phase II-IV, Late Stage Research, Safety...
UBC - May 15, 2015
CEWorks®, UBC’s proprietary web-based software, combines technology and Value Demonstration to allow for rapid and efficient health economics outcomes research (HEOR) without the need to write custom code for each analysis. Healthcare...

Pages