Participants in this training course will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and cellular therapy, and the different ways that CBER and CDER view product development. The course will also discuss proven strategies to achieve regulatory success in the development of biologics.
Course Level: Intermediate
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 cellular therapies
- Differences in how CBER and CDER view product development
- Establishing effective working relationships with CBER and CDER review offices.
Who should attend?
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