Topics
- FDA Centers: CDER, CBER, CDRH
- Review of FDA regulations for biopharma vs. devices
- What is the difference between the requirements for an IND vs. IDE?
- What if the product is a combination product…which do I lead with?
- What is needed for NDA and BLA submissions?
- What are the requirements for a 510k (class I and II) and PMA submissions?
Who should Attend
Distributors or manufacturers of devices, drugs, biologics, or combination products involved in:
- Documentation
- Regulatory Affairs
- Contract manufacturers who provide regulatory submission data for their clients
- CRO personnel who are involved in regulatory submissions
- Quality Assurance
