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Sheraton Philadelphia University City

Oct 23, 2017 7:30 AM - Oct 26, 2017 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 25: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, 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)

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