Agenda
1:30 PM — 5:00 PM
OPDP/APLB AND COMPLIANCE 101: A PRIMER7:30 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 10:30 AM
Session 1 - FDA Update: Recent Enforcement Actions10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2 - Disease Awareness - Education or Promotion?12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3 - Marketing Prescription Products in the Age of Obama3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4 - Question and Answer Session with FDA5:00 PM — 6:00 PM
7:30 AM — 8:00 AM
8:00 AM — 9:30 AM
Session 5 - Leveraging Innovative Technology Compliantly9:30 AM — 10:00 AM
10:00 AM — 11:30 AM
Session 6 - Compliance Update11:30 AM — 12:30 PM
12:30 PM — 1:45 PM
Session 7 Breakout 1 - Substantial Evidence12:30 PM — 1:45 PM
Session 7 Breakout 2 - Supporting Successful Product Launches12:30 PM — 1:45 PM
Session 7 Breakout 3 - Communicating During the Pre-Approval Stages1:45 PM — 2:00 PM
2:00 PM — 3:15 PM
Session 8 Breakout 1 - Substantial Evidence2:00 PM — 3:15 PM
Session 8 Breakout 2 - Supporting Successful Product Launches2:00 PM — 3:15 PM
Session 8 Breakout 3 - Communicating During the Pre-Approval Stages3:15 PM — 3:30 PM
3:30 PM — 4:30 PM
Session 9 - Hot TopicsHave an account?