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Sheraton Philadelphia University City

2017 年 10 月 23 日 7:30 上午 - 2017 年 10 月 26 日 5:00 下午

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 4: Special Topics for Clinical Research

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, 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