Pillar #4: Drug Safety - Pharmacovigilance

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.

• Explain the types of pharmacovigilance, including with their limitations and strengths, and key surveillance systems in the US and globally
• Describe US regulatory requirements for drug safety, including phase 4 post-marketing studies
• Recognize real-world impact of drug safety research and its role in shaping regulatory actions and policies