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Session 25: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA
Session Chair(s)
Drusilla Scott, PHD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
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)