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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

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

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Session 24: 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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