Orphan Drugs 101: The Mini Course

The Orphan Drugs 101: The Mini Course is dedicated to learning the basics and getting rudimentary certification in orphan drug regulatory affairs.

Topics

• 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

Who should Attend

• Regulatory affairs professionals
• Small biotech CEOs
• Anyone working on clinical studies/trials