Agenda
1:30 PM — 5:00 PM
OPDP/APLB and Compliance 101: A Primer8:25 AM — 8:30 AM
Welcome and Opening Remarks8:30 AM — 10:00 AM
FDA Update: Recent Enforcement Actions10:30 AM — 12:00 PM
Substantial Evidence and Other Standards of Evidence in Promotion1:30 PM — 2:30 PM
FDA Guidance Update2:30 PM — 3:30 PM
Social Media: Digital Tools and Considerations in Compliant Development8:30 AM — 10:00 AM
Disease State and Unbranded Materials - Regulatory Challenges8:30 AM — 10:00 AM
Product Communications in the Pre-Approval Phase10:30 AM — 12:00 PM
Disease State and Unbranded Materials - Regulatory Challenges10:30 AM — 12:00 PM
Fundamental Issues in the Regulatory Evaluation of Health Economic Information10:30 AM — 12:00 PM
Product Communications in the Pre-Approval Phase1:30 PM — 2:30 PM
The Next Generation: Promotional Review Boards (Online reviews)3:00 PM — 4:00 PM
Question and Answer Session with FDA4:00 PM — 4:15 PM
Closing RemarksHave an account?