Agenda
10:00 AM — 10:25 AM
Welcoming Remarks and Presentation of the Excellence in Service Award10:25 AM — 11:00 AM
Session 1: Keynote Address: Featured Fireside Chat11:00 AM — 11:30 AM
11:00 AM — 11:30 AM
Exhibit Event – Coffee Corner – hosted by Grant Thornton, LLP11:30 AM — 12:30 PM
Session 2: FDA Plenary – Driving Data and Information Technology12:30 PM — 1:30 PM
2:45 PM — 3:15 PM
3:15 PM — 4:30 PM
Session 4 Track 3: eTMF Collaboration in Outsourced Studies4:45 PM — 5:30 PM
“Happy Hour” in the Exhibit Hall - hosted by Generis10:00 AM — 11:15 AM
Session 5: FDA Electronic Submissions11:15 AM — 11:45 AM
11:15 AM — 11:45 AM
Exhibit Event: Coffee Corner hosted by Genpact11:20 AM — 11:40 AM
Q&A Session: International Regulatory Update11:45 AM — 1:00 PM
Session 6 Track 1: The Crossroads Between Regulatory and Safety1:00 PM — 1:30 PM
2:45 PM — 3:15 PM
3:15 PM — 4:30 PM
Session 8 Track 4: Ad Promo10:00 AM — 11:15 AM
Session 9 Track 2: Enabling R&D Strategy through Automation and Analytics10:00 AM — 11:15 AM
Session 9 Track 3: NextGEN TMF Management Panel– Data is the Key11:15 AM — 11:45 AM
11:20 AM — 11:40 AM
Q&A Session: Global eCTD Specifications11:45 AM — 1:00 PM
Session 10 Track 2: Introducing DIA RIM Reference Model 1.01:00 PM — 1:30 PM
1:10 PM — 1:30 PM
Q&A Session: IDMP – to Iteration 1 and Beyond1:30 PM — 2:45 PM
Session 11: Emerging Technologies Panel2:45 PM — 3:15 PM
3:15 PM — 4:15 PM
Session 12: Ask the Regulators4:15 PM — 4:30 PM
4:15 PM — 5:15 PM
On Demand 1 Track 1: IRISS Forum Hot Topics4:15 PM — 5:15 PM
On Demand 2 Track 1: IDMP – to Iteration 1 and Beyond4:15 PM — 5:15 PM
On Demand 5 Track 4: Global eCTD Specifications4:15 PM — 5:15 PM
On Demand 7: International Regulatory Update4:30 PM — 4:30 PM
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