Agenda
9:30 AM — 10:00 AM
10:00 AM — 5:00 PM
Regulatory Content and Submission Primer: Content from Authoring to Archive7:30 AM — 8:30 AM
11:00 AM — 5:00 PM
12:40 PM — 1:00 PM
DIA Mobile App Tutorial1:00 PM — 1:25 PM
Welcoming Remarks and Presentation of the Excellence in Service Award2:00 PM — 2:45 PM
2:45 PM — 4:00 PM
Session 2: FDA Plenary5:25 PM — 6:30 PM
5:45 PM — 6:30 PM
Speed Networking Hosted by the DIA Diversity in Life Sciences Community7:30 AM — 8:30 AM
7:30 AM — 5:30 PM
8:30 AM — 9:45 AM
Session 4: FDA: Digital IND Safety Reporting9:55 AM — 10:55 AM
Session 5: FDA - Ask the Regulators: Electronic Submissions and eCTD Panel10:45 AM — 11:15 AM
11:15 AM — 12:30 PM
Session 10 - Concurrent Session11:15 AM — 12:30 PM
Session 6 - Concurrent Session11:15 AM — 12:30 PM
Session 6 Track 1: RIM Reference Model: 2019 Progress/Call for Engagement11:15 AM — 12:30 PM
Session 7 - Concurrent Session11:15 AM — 12:30 PM
Session 8 - Concurrent Session11:15 AM — 12:30 PM
Session 9 - Concurrent Session12:30 PM — 2:00 PM
12:30 PM — 2:00 PM
Solution Showcase Theater3:15 PM — 4:15 PM
4:15 PM — 5:30 PM
Session 8 Track 2: Driving Process Optimization with Unified RIM4:15 PM — 5:30 PM
Session 8 Track 3: Analytical Driven Trial Design4:15 PM — 5:30 PM
Session 8 Track 4: The Value of Vendor Relationships6:30 PM — 8:00 PM
7:30 AM — 8:30 AM
7:30 AM — 2:00 PM
9:45 AM — 10:30 AM
10:30 AM — 11:45 AM
Session 10 Track 1: IRISS Forum – Hot Topics10:30 AM — 11:45 AM
Session 10 Track 4: eCTD AdPromo Panel Discussion11:45 AM — 1:15 PM
1:15 PM — 2:00 PM
Session 11: FDA - Ask the Regulators: International Panel2:00 PM — 2:15 PM
2:15 PM — 2:15 PM
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