110 – Adverse Event Reporting Explained (S8E5)

This episode provides a detailed explanation of adverse event reporting, covering how these events are identified, reported, and analyzed. We explore systems like FAERS (FDA Adverse Event Reporting System) and discuss regulatory requirements, reporting processes, and industry responsibilities. The discussion highlights the importance of accurate and detailed reporting in ensuring drug safety.The conversation also delves into real-world examples of high-profile adverse events, their impact, and how regulatory agencies responded. We'll examine the challenges of underreporting and signal detection, and look ahead to future improvements in pharmacovigilance. The main goal is to make clear all the steps involved in reporting.