Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 25, 2018 11:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

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

Back to Agenda

Session 24: 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)

Have an account?