• 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 cellular therapies
• Differences in how CBER and CDER view product development
• Establishing effective working relationships with CBER and CDER review offices.

Professionals involved in:

• Regulatory affairs
• Government and academia
• Quality assurance and manufacturing
• Project management

At the conclusion of this activity, participants 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 strategy differences for successful interactions with FDA CDER and CBER review offices
• Discuss the regulatory mechanisms available to speed biologics development
• Explain current regulatory, global, and public opinion trends that impact biologics