Pharmacovigilance (PV)—the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems—is a dynamic and rapidly changing area of the pharmaceutical industry. As a critical component of ensuring consumer safety, the role of pharmacovigilance has been shaped by several historic events, as well as an increased understanding of the factors that affect drug safety. While there are differences in adverse event reporting obligations among agencies worldwide, recent initiatives have harmonized standards and practices within the industry. Despite these efforts at harmonization, there still remain many regional differences. This will continue to be a major challenge for pharmacovigilance departments as issues such as increased reporting requirements, risk management plans and regional guidances continue to evolve.
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives. You will learn the basic concepts, regulatory requirements, and recent trends and approaches, to understanding and communicating a safety profile.