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Sheraton Boston Hotel

Aug 14, 2017 7:30 AM - Aug 17, 2017 5:00 PM

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 4: Special Topics for Clinical Research

Session Chair(s)

Elliott  Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, 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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