Updates for 2022
Registration to this event provides you virtual access to all components of this meeting. Log-in instructions will be sent to you approximately one week before the start of this event.
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, 2021 2nd Edition
Who Should Attend
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher
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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 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.