アジェンダ
10:00 AM — 1:30 PM
Short Course: The Future of Documents: Deep-Dive into Structured Content10:00 AM — 1:30 PM
Short Course: Structured Data: IDMP is Not the Goal10:00 AM — 5:00 PM
Regulatory Content and Submission Primer: Content from Authoring to Archive9:00 AM — 12:00 PM
BONUS Session: RIM Reference Model 1.0 – Validation Workshop11:00 AM — 5:25 PM
1:00 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 Strategy on Data and Technology Modernization5:25 PM — 6:30 PM
7:30 AM — 8:30 AM
7:30 AM — 5:30 PM
8:30 AM — 9:45 AM
Session 4: FDA Electronic Submissions9:55 AM — 10:45 AM
Session 5: FDA - Ask the Regulators10:45 AM — 11:15 AM
12:30 PM — 2:00 PM
2:00 PM — 3:15 PM
Session 7 Track 3: Rethinking Documents: the Digital Content Revolution3:15 PM — 4:15 PM
4:15 PM — 5:30 PM
Session 8 Track 2: Perspectives on IDMP4:15 PM — 5:30 PM
Session 8 Track 4: eCTD Future7:30 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: Enhancing the Utilization of RIM with Emerging Use Cases10:30 AM — 10:30 AM
Session 10 Track 3: CTD Structured Authoring and the Shift Away from Documents10:30 AM — 11:45 AM
Session 10 Track 4: Making Digital Transformation Real11:45 AM — 1:15 PM
1:15 PM — 2:00 PM
Session 11: FDA - Ask the Regulators2:00 PM — 2:15 PM
2:15 PM — 2:15 PM