Risk Management & Pharmacovigilance

Webinar: The Right Studies for Your Evidence Needs
UBC - October 12, 2016
Register Now:  Free Webinar - 17 November @ 10 a.m. EST As our industry shifts importance from volume to value, it is more important than ever to have a strategic approach to collecting and analyzing evidence. UBC offers a robust...
Hybrid Study for Pharmaceutical Value Messages
Erwin De Cock, Scientific Consultant and Kristy Hanson, Scientific Consultant - August 25, 2016
Real-world data on effectiveness, safety, and other outcomes are increasingly being demanded by multiple stakeholders. Data can be obtained using secondary data sources (electronic medical records, claims/administrative data, existing...
FDA guidance for rare diseases
Irene Pan, MSc, Senior Research Scientist - August 18, 2016
By definition, a rare disease affects less than 200,000 Americans.1 Currently, there exists an estimated 5000-8000 rare diseases affecting more than 25 million Americans.2 The lack of adequate understanding of the pathophysiology and...
HRU and Cost Analysis in EU-5
Erwin De Cock, Scientific Consultant - August 11, 2016
Databases are essential tools for pharmacoeconomic research. While North America has large administrative claims databases, hospital databases, and electronic medical record systems, databases in Europe are scarcer, integrated primary...
Observational Studies for Biosimilars | UBC
Stella Mokiou, Research Scientist II, and Erwin De Cock, Scientific Consultant - July 27, 2016
Biosimilar agents are similar but non-identical versions of existing biological drugs and may be authorized for use once the patent on the reference product has expired. Based on a recent market forecast of IMS, biosimilars are...