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:

  • A binder of speaker handouts and related reference materials.
  • Access to an electronic copy of the FDCA Statutory Supplement, 2018.

Who Should Attend

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

venue sponsor

Register by February 20 and SAVE!

Industry & Firms

$1199
  • +$400 for non-members
  • +$100 after 2/20/20

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Government

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Academic

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Student

$99
  • full-time students only
  • transcripts required
Register Now

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

subject to change

Curriculum Advisor:  Patrick C. Gallagher, Partner, Duane Morris LLP

Wednesday, April 1

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

8:35–9:05 AM
Overview of Biological Products Law and Regulation

9:05–9:35 AM
FDA’s Regulatory Processes

9:35–9:50 AM
Networking and Refreshment Break

9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products

11:05–12:05 PM
Regenerative Medicine and Advanced Therapies (RMATs)

12:05–1:05 PM
Networking Lunch

1:05–2:20 PM
Regulation of Biological/Drug Development

2:20–3:30 PM
Biological License Applications (BLA)

3:30–3:45 PM
Networking and Refreshment Break

3:45–5:00 PM
Biosimilar Biological Products

Thursday, April 2

8:00–8:30 AM
Registration and Continental Breakfast

8:30–9:45 AM
Post-Approval Safety Issues

9:45–10:00 AM
Networking and Refreshment Break

10:00–11:15 AM
Regulation of Biological Manufacturing

11:15–12:30 PM
Regulation of Biological Marketing

12:30–1:45 PM
Networking Lunch

1:45–2:45 PM
New, Emerging, and Continually Interesting Issues

2:45–3:00 PM
Networking and Refreshment Break

 3:00–4:30 PM
Violations, Enforcement, and International Issues

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

Conference Location

Duane Morris LLP
505 9th Street, NW
Suite 1000
Washington, DC 20004

Overnight Accommodations

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.