What you will learn
• 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 CBER views product development compared to CDER



Learning Objectives:
At the conclusion of this course, participants should be able to:
• Discuss specific regulatory requirements for biologics regulated by CBER
• Define expectations of CBER and how they differ from those of CDER
• Identify the unique aspects in the development of specific biologics such as vaccines and gene therapy
• Assess unique characteristics of biologics and why development differs from small molecules.
• Compare the differences in regulatory needs and requirements for biologics compared to small molecules
• Evaluate the differences in how CBER view product development compared to CDER

Target Audience:
Professionals involved in:
• Regulatory affairs
• Quality assurance
• Project management

Event Code:
10422