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SESSION 2: THE IND IN DETAIL – MODULES 1, 2, & 5
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
- IND ITEM: Form FDA 1571
- IND ITEM: Table of contents
- IND ITEM: Introductory statement
- IND ITEM: General investigation plan
- IND ITEM: Investigator’s brochure
- IND ITEM: Protocols
Speaker(s)
THE IND IN DETAIL – MODULES 1, 2, & 5
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
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