This course provides a comprehensive overview of drug safety and pharmacovigilance. We start with the fundamentals of pharmacovigilance and regulatory requirements, including phase 4 post-marketing safety studies. We discuss passive and active surveillance methods, exploring key surveillance systems in the US and globally. The course concludes with real-world examples, demonstrating how drug safety research impacts regulatory decisions and prescribing practices.
What you'll learn
understand the fundamentals of pharmacovigilance
identify regulatory requirements surrounding drug safety
discuss various surveillance methods and their applications
apply knowledge to real-world examples of drug safety research
Course objectives
provide a comprehensive overview of drug safety principles
explain the role of pharmacovigilance in healthcare
integrate practical examples to illustrate key concepts