Risk Management & Pharmacovigilance

Natalie O’Donnell, Executive Director, Safety, Epidemiology, Registries & Risk Management - March 22, 2019
How do you determine if a REMS is needed during product development? A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance. The types of REMS as defined by the...
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Gretchen Dieck, MPhil, PhD, Vice President, Safety, Epidemiology, Registries & Risk Management, Ben Newton, Software Engineer, Database Analytics Automation, and Jamie Reifsnyder, Business Analyst, Database Analytics Automation - March 18, 2019
UBC Has You Covered UBC is introducing PVPlan™ automated software for signal management and tracking for pharmacovigilance (PV). The easy-to-use, point-and-click interface lets you track and manage your PV team with ease, while...
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Wenda Brennan, RPh, Vice President, Global Safety & Pharmacovigilance - March 14, 2019
Traditionally, sources of adverse event reporting included the clinical trial investigator sites, post marketing medical information call centers, and local QPs in Europe.  However, currently, potential adverse event reporting is...
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Irene Cosmatos, Senior Research Specialist, Database Analytics Automation, Dr. Ruben M. Ayzin Rosoky, Senior Safety Physician - February 27, 2019
I was pleased to recently attend and present at the SCOPE Conference in Orlando, FL. The following summarizes the presentation (coauthored by my colleague, Ruben M. Ayzin Rosoky, MD, PhD, MFPM, Senior Safety Physician, UBC...
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Gretchen Dieck, MPhil, PhD, Vice President, Safety, Epidemiology, Registries & Risk Management, Ben Newton, Software Engineer, Database Analytics Automation, Jamie Reifsnyder, Business Analyst, Database Analytics Automation - February 26, 2019
EudraVigilance is the key organizational construct for the European Economic Area (EEA) and is anchored by a central database containing safety reporting (adverse events) and suspected unexpected serious adverse reactions (SUSARs) for...
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