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.
- 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
- 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
These valuable takeaways will be provided onsite:
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher
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