Essentials of Working with FDA for Patient Organizations
June 16-17, 2026 | Virtual Course
Overview
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. More information on this program will be forthcoming to registered attendees of the course.
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.
Sponsorship Opportunities
Sponsorship opportunities are available. At the $5,000 Gold Sponsorship Level, sponsors receive the following benefits, in addition to those listed below at the $2,500 sponsorship level:
- FDLI to read written overview of who the organization is and what its focus entails to attendees during the training;
- Sponsors are able to recommend a list of patient advocates and organizations as prospective attendees for FDLI who will be accepted to attend the event so long as they are staff at or volunteers for a 501(c)(3) patient advocacy organization; and
- Sponsors will be provided with a graphic to share with their community partners to raise awareness of this event.
At the $2,500 Silver Sponsorship Level, sponsors receive the following benefits:
- Logo that links to the sponsor’s website to be placed on FDLI’s website under course registration and information page;
- Logo to be included on course attendee and marketing materials;
- Logo to be included on the course platform during the program;
- A sponsor-specific wrap report to be provided to the sponsor with a list of attendees who attended the event, along with their organizations; and
- An opportunity for the sponsor to attend a 30-minute meeting with the FDLI team to discuss the sponsor-specific wrap report, and to facilitate a feedback and insight exchange.
Please let us know if you would like more information. We appreciate your consideration.
Gold
Silver
Planning Committee
Mitchell Berger, FDA – CBER
Ryan Matthew Hohman, Friends of Cancer Research
Barbara Jones-Binns, Alston & Bird LLP
Natalie Oehlers, Buchanan Ingersoll & Rooney PC
Kathleen Retterson, ELIQUENT Life Sciences
Cara Tenenbaum, Strathmore Health Strategy
David Weiss, Rutgers University
Sarah Wicks, Hyman, Phelps & McNamara, PC
