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Session 25: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, 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)