Updates for 2022

FDLI remains committed to providing high-quality educational programs in a way that keeps our members and event attendees safe. With this in mind, we are excited to announce that the Introduction to Biologics and Biosimilars Law and Regulation course will be a hybrid event (both in-person and virtual). Please note that all in-person plans are subject to change as needed to protect the health and safety of the FDLI community.

Explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A is provided.

Agenda Highlights

  • Regulatory processes for biologics
  • Review and approval process
  • Regulation of biological/drug development
  • Biologics License Application (BLA)
  • Biosimilar biologic products
  • Post-approval safety issues
  • Regulation of biological manufacturing
  • Advertising and promotion requirements
  • Enforcement tools and procedures
  • Changes to the statutory framework for regenerative medicine

Statutes Covered

  • The 1902 Biologics Act
  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Public Health Service Act of 1944 (PHSA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Prescription Drug User Fee Act and Biosimilars User Fee Act
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

 

Register by Fall 2022 and SAVE!

Industry & Firms

$1299
  • +$400 for non-members
  • +$100 Fall 2022

Non-Profit

$799
  • +$200 for non-members
  • +$100 Fall 2022

Government

$799
  • +$200 for non-members
  • +$100 Fall 2022

Academic

$799
  • +$200 for non-members
  • +$100 Fall 2022

Student

$99
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.

Last Year’s Agenda

 

Tuesday, October 5

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

12:05–1:15 PM
Overview of Biological Products Law and the Regulation and FDA’s Regulatory Processes
Nathan A. Beaver, Partner, Foley & Lardner LLP

1:15–1:25 PM
Break

1:25–2:40 PM
Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.

2:40–2:50 PM
Break

2:50–3:50 PM
Regulation of Biological/Drug Development
Natasha V. Leskovsek, Of Counsel, Cooley LLP

3:50–4:00 PM
Break

4:00–5:00 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Nathan Beaton, Associate, Latham & Watkins LLP

 

 

 

Wednesday, October 6

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

12:05–1:15 PM
Biologics License Applications (BLA)
Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International

1:15–1:25 PM
Break

1:25–2:40 PM
Biosimilar Biological Products
Alexandra Valenti, Partner, Goodwin Procter LLP
Steven S. Tjoe, Senior Associate, Goodwine Procter LLP

2:40–2:55 PM
Break

2:55–4:05 PM
Post-Approval Pharmacovigilance
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

4:05–4:20 PM
Break

4:20–5:00 PM
New, Emerging, and Continually Interesting Issues
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

Thursday, October 7

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

12:05–1:20 PM
Regulation of Biological Manufacturing
Christina M. Markus, Partner, King & Spalding LLP

1:20–1:30 PM
Break

1:30–2:45 PM
Regulation of Biological Marketing
Kevin M. Madagan, Partner, Reed Smith LLP

2:45–3:00 PM
Break

3:00–4:30 PM
Violations, Enforcement, and International Issues
James R. Johnson, Partner, Sidley Austin US LLP

4:30 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

 

Location and Overnight Accommodations

Course Location

1032 15th Street, NW
Washington, DC 20005

Parking and Public Transportation

Overnight Accommodations