AE and SAE Reporting: Your Role in Patient Safety

ELM-821 AE and SAE Reporting: Your Role in Patient Safety emphasizes your role as a guardian of safety at a life science company. Designed for all employees, from reception to the shop floor, you’ll become familiar with the vital part that you play in maintaining patient well-being. You’ll follow Sam, a Finance department team member at a pharmaceutical company, who attends a weekend barbeque, where he hears about a friend’s odd reaction while taking one of his company’s products. Through this story, you’ll learn about Adverse Events (AEs) and Serious Adverse Events (SAEs) and how to capture the minimum criteria necessary to make a potentially life-saving report. You’ll also discover how a casual interaction you may be involved in starts the regulatory clock for your entire company and learn why immediate reporting is a mandatory responsibility necessary to protect patients.