アジェンダ
1:30 PM — 5:00 PM
Tutorial: OPDP/APLB 101: A Primer Based on Today’s Changing Environment7:30 AM — 8:30 AM
7:30 AM — 6:00 PM
8:30 AM — 8:45 AM
8:45 AM — 10:30 AM
Session 1: Ad-Promo Litigation: Amarin and Beyond10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2: Engaging Payers, Nontraditional, and Emerging Customer Markets12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3B: Global Promotion Review Process and Standards1:30 PM — 3:00 PM
Session 3C: Mock Review: A Regulatory Perspective3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4B: Global Promotion Review Process and Standards3:30 PM — 5:00 PM
Session 4C: Mock Review: A Regulatory Perspective5:00 PM — 6:00 PM
Poster Session and Networking Reception7:00 AM — 8:00 AM
7:00 AM — 4:00 PM
8:00 AM — 8:05 AM
8:05 AM — 9:35 AM
Session 5: FDA Update: Recent Enforcement Actions and Guidances9:35 AM — 10:00 AM
10:00 AM — 11:30 AM
Session 6: Using New and Emerging Technologies Compliantly11:30 AM — 1:00 PM
11:30 AM — 1:00 PM
Luncheon, Round Table Discussions, and Exhibits1:00 PM — 2:10 PM
Session 7B: Advocacy Groups: When and How Should They be Engaged?1:00 PM — 2:10 PM
Session 7C: Review Standards for Ad Boards and Consultant Meetings2:10 PM — 2:30 PM
2:30 PM — 3:30 PM
Session 8: Compliance Update Panel3:30 PM — 4:00 PM
Closing Session: Question and Answer with FDA