Overview
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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.
Syllabus
- Introduction to Drug Safety
- Pharmacovigilance: Passive Surveillance
- Pharmacovigilance: Active Surveillance
- Applied Examples of Drug Safety Research
Taught by
Jung-Im Shin