Regulatory Affairs for Biologics

This course covers proven strategies to achieve regulatory compliance for the development of biologics, the difference between traditional biologics and biotechnology products, and regulatory needs and requirements for biologics.

• Difference between traditional biologics and biotechnology products
• Regulatory needs and requirements for biologics
• Unique aspects in the development of specific biologics such as vaccines and gene therapy
• Differences in how Center for Biologics Evaluation and Research (CBER) views product development compared to Center for Drug Evaluation and Research (CDER)

Professionals involved in:

• Regulatory affairs
• Quality assurance
• Project management

Participants who complete this course should be able to:

• Discuss product jurisdiction and how it affects the review of biologic products
• Identify the unique aspects of biologics and how their development compares to that of small molecules
• Describe the unique CMC compliance reporting aspects of biologics
• Discuss the regulatory mechanisms available to speed biologics development
• Explain the current regulatory, global, and public opinion trends that have the potential to impact biologics