[IN-PERSON] Half Day Workshop: Mastering FDA Regulations: Strategies for Review and Oversight of Complex Research Scenarios

This Workshop is being offered in-person only; advanced registration is required.

This advanced-level, three-hour workshop is designed for research compliance professionals, regulatory affairs professionals, clinical research coordinators, and others involved in the study, oversight, and regulation of drugs, biologics, and devices. A prerequisite for attendance is a foundational knowledge of FDA research regulations governing human subjects protection and the conduct of clinical trials. Through interactive exercises, immersive case studies, and expert-led presentations, attendees will gain proficiency applying the FDA regulatory framework to advanced scenarios. The workshop will explore real-life examples of research with FDA-regulated products and test articles, including emerging technologies; use existing resources to support regulatory determinations; and consider ongoing oversight with an emphasis on protecting human subjects.