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Part 4: Session 7, Session 8, and Session 9
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 7: The IND In Detail - Additional Topics
- Additional Requirements for Biologics and Biotechnology-derived Products
- Assembly and Submission of an Original IND
- Amendments to the IND
- Annual Reports
- Non-standard INDs
- IND Administrative Actions
- Special Protocol Assessment
- Special Development Pathways
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