Please find the session links next to their corresponding agenda item.

Wednesday, November 30

12:00–1:00 PM

Engaging with FDA: Opportunities and Boundaries
Andrea Furia-Helms, Director, Office of Patient Affairs, Office of the Commissioner, FDA
Michelle Tarver, Director, Patient Science and Engagement, Center for Devices and Radiological Health (CDRH), FDA

Enter this session:

1:05–2:05 PM

Patient Access to Treatments
Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

Enter this session:

2:05–2:20 PM


2:20–3:20 PM

Lessons Learned from COVID-19
Melissa Barhoover, Senior Regulatory Affairs Manager, Becton Dickinson (BD)
Anne Zavertnik, Vice President, Regulatory Affairs, Integrated Diagnostic Solutions, Becton Dickinson (BD)

Enter this session:

3:25–4:25 PM

Hot Topics
Remy Brim, Principal, BGR Group
Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors
Kate Rawson Powell, Senior Editor, Prevision Policy LLC
Moderated by Ryan M. Hohman, Vice President, Public Affairs, Friends of Cancer Research

Enter this session:

4:25 PM

Course Adjournment

CLE Information


This event is pending approval in Ohio. To obtain credit, please email [email protected] at the end of the conference and include your state bar number along with how many credits you wish to obtain. FDLI will certify your attendance for you. An evaluation is required to obtain credit.


This event is pending approval in Virginia. Please email [email protected] to request a Virginia form. You will need to certify your attendance online at Retain the Certificate of Attendance for two years.

Other States

These CLE approvals may also be honored by other states; please check with your bar association for guidance. At the end of the conference, please email [email protected] to receive a certificate of attendance.