The correct implementation of Good Pharmacovigilance Practices has serious, real-life impacts on patients across the globe and the reputation of drug manufacturers.

This course will review recent pharmacovigilance inspections, including the most recent inspections report, remote inspections, and recent inspection findings from for cause and routine inspections over the last few years.

This course also will examine several case studies of warning letters issued to real companies that will help you develop a deeper understanding of how Good Pharmacovigilance Practices must be applied in practice.

At the end of each case study, you’ll review actions that can be taken to mitigate the violations. We’ll also provide a brief overview of  the elements of a successful FDA Form 483 response and a highly effective Pharmacovigilance (PV) program.