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 electronically the day of the course:

Who Should Attend

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


Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • full-time students only

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Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

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.


subject to change

Curriculum Advisor:

Scott M. Lassman, Principal, Lassman Law + Policy


Tuesday, March 9

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

12:05–1:15 PM
Origins and Organizational Structure of FDA and FDA’s Regulatory Processes
Nathan A. Beaver, Partner, Foley & Lardner LLP

1:15–1:25 PM

1:25–2:40 PM
Introduction to FDA Review and Approval of Biological Products
Kellie B. Combs, Partner, Ropes & Gray LLP

2:40–2:50 PM

2:50–3:50 PM
Regulation of Biological/Drug Development
Michael K. Stern, Of Counsel, Covington & Burling LLP

3:50–4:00 PM

4:00–5:00 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Emily Marden, Counsel, Sidley Austin LLP

Wednesday, March 10

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

12:05–1:15 PM
Biologics License Applications (BLA)
Christina M. Markus, Partner, King & Spalding LLP

1:15–1:25 PM

1:25–2:40 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP

2:40–2:55 PM

2:55–4:05 PM
Post-Approval Pharmacovigilance
Abeba Habtemariam, Counsel, Arnold & Porter LLP

4:05–5:00 PM
New, Emerging, and Continually Interesting Issues
Scott M. Lassman, Principal, Lassman Law + Policy

Thursday, March 11

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

12:05–1:20 PM
Regulation of Biological Manufacturing
Scott Kaplan, Counsel, Hogan Lovells US LLP

1:20–1:30 PM

1:30–2:45 PM
Regulation of Biological Marketing
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
Alexandre Gapihan, Associate, Morgan, Lewis & Bockius LLP

2:45–3:00 PM

3:00–4:30 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Partner, McDermott Will & Emory

4:30 PM


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.