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Sheraton Philadelphia University City

2019 年 10 月 14 日 7:45 上午 - 2019 年 10 月 17 日 5:00 下午

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 21: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • GLP Inspections
  • GCP Inspections
  • Inspection Outcomes: Additional Considerations in GCP Inspections
  • GMP Inspections
  • Inspection Outcomes (GLPs, GCPs, GMPs)
  • FDA Enforcement Actions
  • Application Integrity Policy (AIP)
  • Inspection Video (optional)

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