This introductory workshop is an essential resource for professionals involved in the conduct, review, or oversight of FDA-regulated research on drugs, biologics, and medical devices. Designed to build foundational knowledge, the program is ideal for individuals working at academic medical centers, research hospitals, contract research organizations, pharmaceutical or biotechnology companies, and federal agencies—as well as those serving on or supporting institutional review boards (IRBs), quality assurance units, or regulatory affairs offices.
Whether you're a clinical research coordinator, IRB administrator, regulatory specialist, investigator, research compliance officer, or part of a research ethics or legal team, this workshop offers the tools and context needed to navigate FDA human subjects research regulations with confidence.