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Sheraton Philadelphia University City

Oct 14, 2019 7:45 AM - Oct 17, 2019 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Post-Marketing

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

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Session 9: Special Topics in Clinical Research

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

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

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