Day 1

 

Day 2
Resources

Access all of today’s sessions here: https://georgetown.zoom.us/j/94287333199

Thursday, November 12

12:00–12:15 PM

Welcome Remarks

Amy Comstock Rick, President & CEO, FDLI
Paige Samson, Director, Innovative Programs and Publications, FDLI

12:15 – 12:45 PM 

Keynote Address

Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA
Lowell Zeta, Senior Counselor to the Commissioner, Office of the Commissioner, FDA

12:45 – 12:50 PM 

Break

12:50 – 2:20 PM 

Paper Presentations

“History, Legislative Innovation, and Future Pandemics”

Daniel A. Kracov, Arnold & Porter and Vice Chair, FDLI Board of Directors

Download abstract here.

“Agencies Unbound: How COVID-19 Prompted Regulatory Flexibility and How to Build on it for the Future”

Brian D. EyinkElizabeth Barr Fawell, Steven B. Steinborn, and Anneke Baran Altieri, Hogan Lovells US LLP

Download the abstract here.

Moderator:  Laurie Beyranevand, Vermont Law School
Discussant:  Kalah Auchincloss, Greenleaf Health, Inc.

2:20 – 2:30 PM

Break

2:30 – 3:15 PM

Paper Presentation

“The American Pharmaceutical Supply Chain: Will COVID-19 Drive Manufacturing Back Home?”

Gregory H. LevineJenna McCarthy*, and Beth P. Weinman, Ropes & Gray LLP and Grant Sims*, NYU Stern School of Business

Download abstract here.

Moderator:  Marian Lee, Gibson, Dunn & Crutcher LLP
Discussant:   Ralph F. Hall, University of Minnesota Law School and Leavitt Partners, LLC

3:15 – 3:30 PM

Break

3:30 – 5:00 PM

Paper Presentations

“Vaccine-Related Liability: Past Approaches, Current Challenges, and Proposals for Encouraging Future Innovation and More Widespread Vaccine Use”

Camille L. Fletcher, Greg Margolis*, and John D. Winter, Patterson, Belknap, Webb & Tyler LLP

Download abstract here.

“A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

Jeffrey N. Gibbs, and Gail H. Javitt*, Hyman, Phelps & McNamara, P.C.

Download abstract here.

Moderator: James T. O’Reilly, University of Cincinnati, and Chair, Food and Drug Law Journal Editorial Advisory Board
Discussant
:  J.R. McNair, Winston & Strawn LLP

5:00 – 5:30 PM

Networking Event

Enter this session: https://fdli.zoom.us/j/94469027229

FAQ

This course is pending CLE approval in Virginia and Ohio. During the course, there will be periodic polling to ensure you are still listening. This will let us know if you completed the necessary hours to receive CLE credit. Please email [email protected] at the end of the conference to obtain forms.

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Yes. Please contact Coleen Carney at [email protected] if you require dial-in numbers.