Essentials of Working with FDA for Patient Organizations

Please join us for this 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 will gain insight into FDA’s regulatory processes and learn practical tactics for engaging with CBER, CDER, and other FDA offices, such as the Rare Disease Innovation Hub. Participants also will learn changes in mechanisms to engage with FDA under the current administration (such as FDA’s forthcoming plausible mechanism of action approval pathway, FDA expert panels, and more); gain competency in postmarket issues; hear from experts regarding current developments in AI as they relate to diagnoses, clinical trials and drug development, and more; and learn more about clinical trial design and participation as each relates to patient advocacy. 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.