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Session 4: Special Topics for Clinical Research
Session Chair(s)
Drusilla Scott, PHD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- 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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