Date: April 8 and April 15
Time: 9 a.m.-12 p.m. EST

Modules discussed:

• FDA’s Role in Drug Development
• Logic of drug development
• Basics of non-clinical drug testing
• Requirements for an IND
• Basics of clinical trial structure and design (Phase 1, 2, 3 clinical)
• Requirements for an NDA
• Post approval responsibilities of sponsor (Phase 4 clinical)
• Fundamentals of GLP, GCP and GMP

Advanced Registration Required

Note: This workshop will take place via two Zoom sessions. Please note the dates and times of the Zoom sessions below (Must attend both):
Zoom Session 1 - Monday, April 8, 9 a.m.-12 p.m.
Zoom Session 2 - Monday, April 15, 9 a.m.-12 p.m.