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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

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

Session Chair(s)

Elliott Berger, PhD, MS

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)
Inspection Video (optional)

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