European Perspectives

PASS protocols
UBC - October 22, 2015
A recent report from the Pharmacovigilance and Risk Assessment Committee (PRAC) found that in the 200+ study protocols reviewed, nearly half suffered from study design flaws. Don’t let methodological issues stall approval of your next...
UBC - October 20, 2015
At NORD’s Rare Diseases & Orphan Products Breakthrough Summit, key stakeholders and industry leaders of the rare disease community will come together to identify breakthrough treatment options and therapies for patients with rare...
Literature reviews | Safety signal detection
Helena Pontes Pedrosa, Pharm D PhD, Safety Scientist, Pharmacovigilance, and Mallorie Clement, PhD, Associate Director, Pharmacovigilance - September 23, 2015
Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per...
Tagged in:
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...

Pages