Updates for 2021
FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2021 Introduction to Biologics & Biosimilars Law and Regulation Course will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience. Be sure to check the course website regularly for additional announcements and updates.
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:
- 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
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Agenda
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
Break
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
Break
2:50–3:50 PM
Regulation of Biological/Drug Development
Michael K. Stern, Of Counsel, Covington & Burling LLP
3:50–4:00 PM
Break
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
Break
1:25–2:40 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP
2:40–2:55 PM
Break
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
Break
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
Break
3:00–4:30 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Partner, McDermott Will & Emory
4:30 PM
Adjournment
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.