Pharmacovigilance in Early Drug Development

1 Unit · Graduate

Pharmacovigilance is the science dealing with the collection, assessment, monitoring, and prevention of adverse effects of drugs and pharmaceutical products and is a fast-growing area in industry, health sciences, and in regulatory agencies. The course will address the fundamentals of pharmacovigilance especially in the context of early drug development. Topics covered will include causality assessment and management of drug safety during drug discovery, benefit-risk analysis, signal management, and product safety monitoring in clinical trials. Students will learn about how to monitor, recognize, and manage adverse drug reactions, medication errors, issues related to misuse and abuse of drugs, as well as drug safety during pregnancy and pediatric populations. The lectures will be given by experts in the field affiliated with Northwestern University and Abbvie, Inc. A key aspect of the course will include Case studies, which will discuss real published data on assessment of a specific drug or pharmaceutical products. Upon completion of this course, graduate students will demonstrate an understanding of pharmacovigilance and patient safety in the context of early drug development.