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

venue sponsor

Register by September 12 and SAVE!

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Government

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Student

$99
  • full-time students only
  • transcripts required
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A Valuable Reference
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th 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.

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.

Previous Agenda

subject to change
 
Curriculum Advisor: 
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP

 

Tuesday, April 2

8:00–8:30 AM
Registration and Continental Breakfast
 
8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI   
                            
8:35–9:35 AM
Overview of Biological Products Law and Regulation
Suchira Ghosh, Counsel, Axinn, Veltrop & Harkrider LLP
 
9:35–9:50 AM
Networking and Refreshment Break
 
9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP
 
11:05 AM–12:05 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Heather Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP
 
12:05–1:05 PM
Networking Lunch
 
1:05–2:20 PM
Regulation of Biological/Drug Development
Jennifer Nowak, Associate, Holland & Knight LLP
 
2:20–3:30 PM
Biological License Applications (BLA)
Priya Jambhekar, Consultant, EAS Consulting Group, LLC
 
3:30–3:45 PM
Networking and Refreshment Break
 
3:45–5:00 PM
Biosimilar Biological Products
Scott M. Lassman, Partner, Goodwin Procter LLP

Wednesday, April 3

8:00–8:30 AM
Registration and Continental Breakfast
 
8:30–9:45 AM
Post-Approval Safety Issues
Sarah Blankstein, Associate, Ropes & Gray LLP 
 
9:45–10:00 AM
Networking and Refreshment Break
 
10:00–11:15 AM
Regulation of Biological Manufacturing
Todd H. Halpern, Partner, Venable LLP
 
11:15 AM–12:30 PM
Regulation of Biological Marketing
Khelin Aiken, Counsel, McDermott Will & Emery LLP
 
12:30–1:45 PM
Networking Lunch
 
1:45–2:45 PM
New, Emerging, and Continually Interesting Issues
Kalah Auchincloss, Senior Vice President, Greenleaf Health, Inc.
 
2:45–3:00 PM
Networking and Refreshment Break
 
3:00–4:30 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Counsel, Arent Fox LLP
 
4:30 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, 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

Sidley Austin LLP
1501 K Street NW
Suite 600
Washington, DC 20005

Overnight Accommodations

Coming Soon.