New Course Offered at UNC Gillings: Pharmacovigilance

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The UNC Gillings School of Global Public Health is doing something new. This fall for the first time, they are teaching a special topics course in pharmacovigilance as part of their pharmacoepidemiology curriculum.  

Essential Education

A recent survey conducted by the International Society for Pharmacoepidemiology (ISPE) Education Committee showed that more than 80% of respondents considered pharmacovigilance education essential. Pharmacovigilance is the mechanism by which drugs used in real-world clinical settings are monitored and evaluated to help ensure therapeutic product safety. 

Pharmacovigilance Defined

According to the course description, pharmacovigilance is “a set of activities involving safety signal detection, signal assessment, review of evolving risk-benefit evidence, and planning for and evaluating post-market risk minimization measures to assure that benefits continue to outweigh risk in actual use.”

Elizabeth B. Andrews, RTI Health Solutions Vice President of Pharmacoepidemiology and Risk Management, is the course instructor. Dr. Andrews is a world-leading expert in the field and editor of the preeminent textbook on the topic, Mann’s Pharmacovigilance. Several of her RTI-HS colleagues will be contributing by speaking on their area of expertise: Susana Perez-Gutthann, Mary Beth Ritchey, and Alicia Gilsenan.

RTI-HS is proud that our researchers contribute to the future of drug safety by fostering the next generation of pharmacoepidemiologists through high-quality education.

Full Course Description

Pharmacovigilance is the study of the safety of marketed drugs in a usual practice setting.  It refers to responsible stewardship of medications, biological products, and medical devices, or a set of activities involving safety signal detection, signal assessment, review of evolving risk-benefit evidence, and planning for and evaluating post-market risk minimization measures to assure benefits continue to outweigh risk in actual use.  It also includes the planning and evaluation of post-market studies of safety and product utilization.  Many activities involve reporting safety events, periodic benefit-risk summary reports, and safety study reports to health authorities in a highly-regulated environment.  

This course provides an overview of the regulatory framework in the US and Europe, some examples of pharmacovigilance challenges, signal detection using adverse experience and claims databases, benefit-risk assessment methods, and risk management measures and their assessment. 

Course Objectives

Upon completion of this course, successful students will be prepared to:

• Understand the range of activities that are included in the field of pharmacovigilance

• Have a grasp of pharmacovigilance framework and terminology to partner successfully with pharmacovigilance professionals as epidemiologists 

• Understand some of the complexities and limitations of the PV methods in confirming or refuting potential safety signals. 

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