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.

Agenda

Subject to change

All times are in Eastern Time

2022 Curriculum Advisor:
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.

 

Preconference Primer

Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes

Day 1

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM
Introduction to FDA Review and Approval of Biological Products

12:20–12:30 PM
Break

12:30–1:45 PM
Regulation of Biological/Product Development

1:45–1:55 PM
Break

1:55–3:10 PM
Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy

3:10–3:20 PM
Break

3:20–4:35 PM
Biological Product Approval, Vaccines, Emergency Use Authorization

 

 

 

 

 

 

Day 2

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05–12:20 PM
Biosimilar Biological Products

12:20–12:30 PM
Break

12:30–1:15 PM
Post-Approval Pharmacovigilance

1:15–1:25 PM
Break

1:25–2:25 PM
Regulation of Biological Manufacturing

2:25–2:35 PM
Break

2:35–3:35 PM
Regulation of Biological Product Marketing

3:35–3:45 PM
Break

3:45–5:00 PM
Violations, Enforcement, and International Issues

5:00 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. 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