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Sheraton Boston Hotel

Aug 14, 2017 7:30 AM - Aug 17, 2017 5:00 PM

39 Dalton Street, , Boston, MA 02119 , USA

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)

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)

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