Back to Agenda
SESSION 3: SPECIAL TOPICS FOR CLINICAL RESEARCH UNDER AN IND
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
- Adequate and well-controlled trials
- Foreign clinical trials
- Surrogate endpoints
- Disease-specific guidance as resources
- Changes in the investigational drug in phases 2-3
- The Animal rule
- Financial disclosure by clinical investigators
Speaker(s)
SPECIAL TOPICS FOR CLINICAL RESEARCH UNDER AN IND
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
Have an account?