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Part 1: Session 1 and Session 2
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
Session 1: The Drug Development Process: An Overview
- Regulation Highlights
- Key Definitions
- Drug Development Highlights
- Regulatory Strategy
- What is an IND
- When is an IND Required/Not Required
- Types of INDs
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