Preliminary Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Wednesday, May 17
Christine M. Simmon, President & CEO, FDLI
2023 FDLI Annual Conference Co-Chair Introduction
Robert Califf, Commissioner of Food and Drugs, FDA (Invited)
Introduced by Freddy A. Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics and Chair, FDLI Board of Directors
Mark J. Raza, Chief Counsel, FDA
FDLI Distinguished Service and Leadership Award
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.
2:00–3:00 PM | Concurrent Breakout Sessions 1
During this session, FDA leadership will address the top issues CFSAN is facing as well as priorities and goals for the coming year.
Susan T. Mayne, Director, CFSAN, FDA
Douglas W. Stearn, Deputy Director, Regulatory Affairs, CFSAN, FDA
3:15–4:15 PM | Concurrent Breakout Sessions 2
During this session, FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.
Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA (Invited)
4:30–5:30 PM | Concurrent Breakout Sessions 3
During this session, FDA leadership will address the top issues CBER is facing as well as priorities and goals for the coming year.
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
Thursday, May 18
Laura Brown, Director, Educational Programs, FDLI
2023 FDLI Annual Conference Co-Chair Introduction
The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, in furtherance of our mission.
A lectureship in honor of Dr. Harvey W. Wiley, featuring the recipient of the namesake award bestowed by the FDA Alumni Association.
11:00 AM–12:00 PM | Concurrent Breakout Sessions 4
During this session, FDA leadership will address the top issues CDER is facing as well as priorities and goals for the coming year.
Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA (Invited)
1:00–2:00 PM | Concurrent Breakout Sessions 5
During this session, FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.
Tracey Forfa, Acting Director, Center for Veterinary Medicine, FDA (Invited)
2:10–3:10 PM | Concurrent Breakout Sessions 6
During this session, FDA leadership will address the top issues CTP is facing as well as priorities and goals for the coming year.
Brian King, Director, Center for Tobacco Products, FDA
Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2021, and Cases to Watch, 2022.
