Interact with and learn directly from the U.S. Food and Drug Administration's (FDA) regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions.
Drugs Track (Aug 25-26): This year’s agenda will complete our series of the regulatory timeline which we started in REdI 2018External Link Disclaimer. We will focus on “Post Approval Considerations” as we address the regulatory aspects of selected topics and utilize case studies to exemplify best practices within those areas.
Devices Track (Aug 27-28): A core theme of this program is to consider the role of risk, and risk-benefit into regulatory decisions to help advance the development of safe and effective medical devices. This program also uses examples and specific case studies to provide a hands-on experience to reinforce the regulatory principles described.
This event is a collaboration between the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE).