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

Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 15, 2019 5:00 PM

One Seaport Lane, Boston, MA 02210

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

Back to Agenda

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

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., 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)

Have an account?