This training course will provide an opportunity to increase one’s knowledge and understanding of emerging FDA legal and regulatory issues related to the COVID-19 pandemic and an update on emerging issues. The course begins with laying the foundation with providing an overview of the legal framework of the Emergency Use Authorization (EUA), the Public Readiness and Emergency Preparedness Act (Prep), and current and future enforcement guidelines and liabilities.  Day two of the course will identify new and developing policies and procedures affecting all phases of diagnostic and laboratory testing, emerging issues on drug issues, vaccines, PPE’s, ventilators, and 3D printed devices.

Register

Industry & Firms

$599
  • +$200 for non-members

Non-Profit

$499
  • +$200 for non-members

Government

$499
  • +$200 for non-members

Academic

$499
  • +$200 for non-members

Student

$99
  • full-time students only
Register Now

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To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Agenda

Curriculum Advisors

Cathy L. Burgess, Partner, Alston & Bird LLP, Member, FDLI Board of Directors
Gregory H. Levine, Partner, Ropes & Gray
John F. Johnson, Of Counsel, Shook, Hardy & Bacon, LLP
Karen C. Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

 

Tuesday, August 18

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Defining Emergency Use Authorization (EUA) Authorities
Cathy L. Burgess, Partner, Alston & Bird LLP,  Member, FDLI Board of Directors

1:05–1:15 PM
Break

1:15–1:45 PM
Public Readiness and Emergency Preparedness Act (PREP ACT)
Joshua Oyster, Senior Associate, Ropes & Gray LLP

1:45–1:55 PM
Break

1:55–2:40 PM
Enforcement Action Guidelines, Legal Liabilities and Concerns Down the Road
Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP
Angela M. Seaton, Partner, Shook, Hardy & Bacon LLP

2:40–2:55 PM
Break

2:55–3:40 PM
Combating Fraudulent Products
Cathy L. Burgess, Partner, Alston & Bird LLP,  Member, FDLI Board of Directors

Wednesday, August 19

12:05–12:50 PM
Diagnostics, Laboratory Testing
Beth P. Weinman, Counsel, Ropes & Gray LLP

12:50–1:00 PM
Break

1:00–2:00 PM
Personal Protection Equipment (PPE)
Sung W. Park, Associate, Reed Smith LLP

2:00–2:15 PM
Break 

2:15–3:00 PM
Ventilators and 3D Printed Devices
Benjamin Wolf, Senior Associate, Alston & Bird LLP 

3:00–3:15 PM
Break

3:15–4:15 PM
Drug Issues: Therapeutic Agents, Vaccines, Inspections, and Supply Chain Challenges
Cathy L. Burgess, Partner, Alston & Bird LLP,  Member, FDLI Board of Directors

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.