アジェンダ
7:30 AM — 5:30 PM
8:30 AM — 12:00 PM
Tutorial – IDMP: “Start Early, Finish Strong”1:00 PM — 1:10 PM
Welcome and Opening Remarks1:10 PM — 1:45 PM
Keynote Address1:45 PM — 3:15 PM
Plenary Session 1 - FDA Update3:15 PM — 3:45 PM
3:45 PM — 5:15 PM
Plenary Session 2 - Other Regions Update5:15 PM — 6:15 PM
7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 1 Track 2 - M1: Ad/Promo10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 2 Track 1 - Working With Affiliates10:30 AM — 12:00 PM
Session 2 Track 2 - Optimizing Global Submissions12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3 Track 1 - Next Generation Regulatory Operations1:30 PM — 3:00 PM
Session 3 Track 2 - ERS Diverse Processes3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4 Track 1 - DIA Regulatory Affairs Community Update3:30 PM — 5:00 PM
Session 4 Track 2 - eCTD v4/RPS; Moving Towards Implementation3:30 PM — 5:00 PM
Session 4 Track 3 - Technology Enablers to Optimize EDM7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 5 Track 2 - Submission Production Potpourri8:30 AM — 10:00 AM
Session 5 Track 3 - Connection with CROs10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6 Track 1 - RIM Working Group: Thought Leadership on a Complex Issue10:30 AM — 12:00 PM
Session 6 Track 2 - Reg Ops Optimization/Lessons Learned10:30 AM — 12:00 PM
Session 6 Track 3 - Trial Master File 2.0...What’s Next?10:30 AM — 12:00 PM
Session 6 Track 4 - Technology Considerations for Next Generation RIM solutions12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 7 Track 4 - Trends and Opportunities in Master Data Management3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Closing Plenary - "Ask The Regulators" Session5:00 PM — 5:15 PM
Closing Remarks