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Part 3: Session 5 and Session 6
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 5: IND in Detail - Item 7
- Chemistry, Manufacturing and Controls
- IND Item 8: Nonclinical Pharmacology and Toxicology
- IND Item 9: Previous Human Experience
- IND Item 10: Additional Information
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