Essentials of Working with FDA for Patient Organizations

Please join us for this reimagined, complimentary two-day training program, where FDLI brings together law, industry, and FDA experts with deep expertise to equip patient advocates and organizations with an understanding of the legal tools and strategies available for interacting with the agency. In this complimentary course, participants gain insight into FDA’s regulatory processes and learn practical tactics for engaging with CBER, CDER, CDRH, the Rare Disease Innovation Hub, and other FDA offices. Participants also will learn about the changes in FDA’s leadership, structure, and goals under the new administration; gain competency in navigating insurance as it relates to HIPAA, GINA, and ERISA; and learn more about clinical trial design and participation as each relates to patient advocacy. Join us in-person to take advantage of networking opportunities with your peers! It is recommended that participants complete the ProgressForPatients.org Advocacy Education Program for background information and to prepare for the live sessions.

All training sessions are subject to change.

This course is open to staff and volunteers of 501(c)(3) patient or disease organizations. Applications will be considered on a case-by-case basis.