Risk Management & Pharmacovigilance

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...
UBC - October 06, 2015
During the month of October, we’re joining the American Pharmacists Association to celebrate the integral role that pharmacists play in the healthcare of patients. The theme “Know your Pharmacist, Know your Medicine” inspired us to...
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...
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UBC - September 10, 2015
Disparate databases containing spontaneous safety reports vary in quality, quantity and format, making it difficult to leverage these databases to identify and investigate safety signals. CLÆRITY® standardizes the coding of drugs,...

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