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Part 2: Session 3 and Session 4
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 3: The IND in Detail - Items 1-6
- IND Item 1: Form FDA 1571
- IND Item 2: Table of Contents
- IND Item 3: Introductory Statement
- IND Item 4: General Investigation Plan
- IND Item 5: Investigator’s Brochure
- IND Item 6: Protocols
- Adequate and Well-controlled Trials
- Adaptive Study Designs
- Comparative Effectiveness Research (CER)
- Patient Reported Outcomes
- Surrogate Endpoints
- The Animal Efficacy Rule
- Qualification of Drug Development Tools
- Foreign Clinical Trials
- Changes to the Investigational Drug
- Financial Disclosure by Clinical Investigators
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