The Orphan Drugs 101: The Mini Course is dedicated to learning the basics and getting rudimentary certification in orphan drug regulatory affairs.
The Orphan Drugs 101: The Mini Course covers topics such as:
- The FDA/EMA Orphan Designation
- The anatomy and physiology of the FDA
- The Pre-IND meeting/ meetings with FDA in general
- The RPDD/PRV
- Accelerated approval and the 505(b)(2) process
The Orphan Drugs 101: The Mini Course brings together:
- Regulatory affairs professionals
- Small biotech CEOs
- Anyone working on clinical studies/trials