Why Attend

Preliminary Agenda

CLE

Tuesday, December 15

11:30 – 11:45 AM
FDLI Welcome and Introductions

Amy Comstock Rick, President & CEO, FDLI
Sonali P. Gunawardhana, Counsel, Shook, Hardy & Bacon LLP and Chair, 2020 Enforcement, Litigation, and Compliance Conference

11:45 AM –12:15 PM
Keynote Address

Daniel Feith, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, US Department of Justice (Invited)

12:15–12:30 PM
Visit and Explore

Visit the lobby, sponsor booths, and learn about networking opportunities with fellow attendees during the conference.

12:30–2:15 PM
Compliance Central with FDA Center Compliance Directors: Part I – Presentations

Donald D. Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA (Invited)
William A. Correll, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA (Invited)
William Maisel, Director, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA (Invited)
Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA (Invited)
Timothy C. Schell, Director, Division of Compliance, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA (Invited)
Ann L. Simoneau, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA (Invited)

This two-part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2020. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and what to expect when you don’t follow FDA regulations.

2:45–3:00 PM 
Networking Break

2:45–3:00 PM 
Concurrent Breakout Sessions

  • The Future of EUAs: What Happens Post-Crisis
  • Evolving Off-Label Enforcement Theories
  • Pandemic-Related Food Labeling Policies: What Has Changed and Will Any New Policies be Long-Term?
  • The Premarket Tobacco Product Application Deadline Has Passed – What is the Current State of Enforcement?

4:00–4:15 PM 
Networking Break

4:15–5:15 PM 
Enforcement and Litigation Related to COVID-19

5:15–5:45 PM 
Daily Download
Join a Zoom group of your choice to network and discuss hot-button issues that were brought up during the day. Coffee or cocktail optional!

Wednesday, December 16

11:30 AM – 12:25 PM
Virtual Luncheon with Table Topic Discussions

12:25 – 12:30 PM
FDLI Welcome
Laura Brown
, Director, Educational Programs, FDLI

11:45 AM –12:15 PM
Address: Eighth Annual Eric M. Blumberg Memorial Lecture

1:00–2:00 PM
Global Supply Chains: Current Issues and Managing Risk

2:00–2:15 PM
Networking Break 

2:15–3:15 PM
Concurrent Breakout Sessions  

  • FDA Inspections in the Age of COVID-19
  • Digital Health: Enforcement, Regulations, and Risks
  • Hot Button Issues and Trends in State and Local Government Tobacco Regulation and Enforcement

3:15–3:30 PM
Networking Break

3:30–4:30 PM
Concurrent Breakout Sessions

  •  Quality Risk Management (QRM) During a Pandemic and After: Essential Components of Risk Management During a Public Health Crisis
  • Regenerative Medicine: Policy, Innovation, and Risk Management for Emerging Technologies
  • FTC Litigation and Application to FDA Authorities

4:30–4:35 PM
Transition 

4:35–5:30 PM
Top Trends and Cases in FDA and DOJ Criminal Enforcement 

5:30 PM
Closing Remarks and Adjournment