アジェンダ
10:00 AM — 5:00 PM
Regulatory Content and Submissions Primer8:30 AM — 12:00 PM
Course 1: Global Identification of Medicinal Products (IDMP)8:30 AM — 12:00 PM
Course 3: Achieving Regulatory Operations Excellence Through Outsourcing12:45 PM — 1:00 PM
1:00 PM — 1:25 PM
Welcome and Opening Remarks2:00 PM — 3:30 PM
Plenary Session 1: FDA - PDUFA V Update3:30 PM — 4:00 PM
4:00 PM — 5:30 PM
Plenary Session 2: Other Regions Update5:30 PM — 6:30 PM
7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 1: FDA Data Standards and Regulatory Compliance Update10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 2 Track 1: Business Impacts to IDMP10:30 AM — 12:00 PM
Session 2 Track 2: Regulatory Analytics10:30 AM — 12:00 PM
Session 2 Track 3: EDMS in the 21st Century, Better, Broader, More Flexible10:30 AM — 12:00 PM
Session 2 Track 4: Ad/Promo12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3 Track 1: What is RIM?1:30 PM — 3:00 PM
Session 3 Track 4: The Future of Electronic Submissions3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4 Track 2: Use of Regulatory Data3:30 PM — 5:00 PM
Session 4 Track 4: Publishing Pet Peeves and Practical Pointers7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 5 Track 1: Registration Management8:30 AM — 10:00 AM
Session 5 Track 2: IDMP Technology Focus8:30 AM — 10:00 AM
Session 5 Track 4: Following the Sun: Regulatory Ops in Global Organization10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6 Track 1: Save $60 Million – The Easy Way10:30 AM — 12:00 PM
Session 6 Track 2: Structured Content Management12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 7: FDA Electronic Submissions Update3:00 PM — 3:15 PM
3:15 PM — 4:45 PM
Closing Plenary: "Ask the FDA"4:45 PM — 5:00 PM
Closing Remarks