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Regulatory Submissions, Information, and Document Management Forum

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

Agenda

Day 1 Feb 08, 2022

10:00 AM — 1:30 PM Short Course: The Future of Documents: Deep-Dive into Structured Content

Day 2 Feb 09, 2022

10:00 AM — 1:30 PM Short Course: Structured Data: IDMP is Not the Goal

Day 3 Feb 13, 2022

10:00 AM — 5:00 PM Regulatory Content and Submission Primer: Content from Authoring to Archive

Day 4 Feb 14, 2022

8:30 AM — 9:00 AM BONUS Session Registration *No additional fee or separate registration is required. This Workshop is open to all
9:00 AM — 12:00 PM BONUS Session: RIM Reference Model 1.0 – Validation Workshop
11:00 AM — 5:25 PM Forum Registration
1:00 PM — 1:25 PM Welcoming Remarks and Presentation of the Excellence in Service Award
1:25 PM — 2:00 PM Session 1: Keynote Address - How To Think Like an Innovator in a World of Uncertainty
2:00 PM — 2:45 PM Refreshment and Networking Break in the Exhibit Hall
2:15 PM — 2:45 PM Exhibitor Event: Regulatory Execution of Mergers, Acquisitions, and Divestitures (Virtual Exclusive)
2:45 PM — 4:00 PM Session 2: FDA Strategy on Data and Technology Modernization
4:10 PM — 5:25 PM Session 3: Progress Towards Structured Submission Documents: ICH M11 and the Clinical Electronic Structured Harmonized Protocol (CeSHarP)
5:25 PM — 6:30 PM Networking Reception in the Exhibit Hall

Day 5 Feb 15, 2022

7:30 AM — 8:30 AM Networking Breakfast in the Exhibit Hall
7:30 AM — 5:30 PM Registration
8:30 AM — 9:45 AM Session 4: FDA Electronic Submissions
9:55 AM — 10:45 AM Session 5: FDA - Ask the Regulators
10:45 AM — 11:15 AM Refreshment and Networking Break in the Exhibit Hall
11:15 AM — 12:30 PM Session 6 Track 1: Application of RIM in Medical Devices – Challenges and Opportunities for Automation
11:15 AM — 12:30 PM Session 6 Track 2: Driving Data Integration, Data Governance, and Data Quality Monitoring Through Data Standards
11:15 AM — 12:30 PM Session 6 Track 3: Inspection Readiness: Different Approaches to Inspection Readiness with Real-World Case Studies and Inspection Outcomes from Sponsors
11:15 AM — 12:30 PM Session 6 Track 4: Structured Content: Where Are We Now, Where Are We Going, and Practical Applications
12:30 PM — 2:00 PM Networking Luncheon in the Exhibit Hall
2:00 PM — 3:15 PM Session 7 Track 1: Innovation Across the Regulatory Spectrum: A Call to Action for Industry
2:00 PM — 3:15 PM Session 7 Track 2: Implementation Experience Sharing: Next-generation Global RIM Solutions
2:00 PM — 3:15 PM Session 7 Track 3: Rethinking Documents: the Digital Content Revolution
2:00 PM — 3:15 PM Session 7 Track 4: It’s All About the Data! From Case Report Forms to Datasets, What Does FDA Need to Approve your Submission?
3:15 PM — 4:15 PM Refreshment and Networking Break in the Exhibit Hall
4:15 PM — 5:30 PM Session 8 Track 1: Establishing Data Quality & Data Governance Frameworks
4:15 PM — 5:30 PM Session 8 Track 2: Perspectives on IDMP
4:15 PM — 5:30 PM Session 8 Track 3: Acquiring the Knowledge to Survive a Merger - Pregame and Post-game
4:15 PM — 5:30 PM Session 8 Track 4: eCTD Future

Day 6 Feb 16, 2022

7:30 AM — 8:30 AM Networking Breakfast in the Exhibit Hall
7:30 AM — 2:00 PM Registration
8:30 AM — 9:45 AM Session 9 Track 1: The Only Constant is Change; How Will Emerging Data Standards Affect Global Regulatory Processes
8:30 AM — 9:45 AM Session 9 Track 2: Key Intelligent Automation and Advanced Technology Use Cases in Regulatory
8:30 AM — 9:45 AM Session 9 Track 3: From Sites to Health Authorities – Lessons Learned on Document Preparation and Exchange
8:30 AM — 9:45 AM Session 9 Track 4: Managing Chaos, Time and Submissions: Organizing and Executing Global Submission Strategy
9:45 AM — 10:30 AM Refreshment and Networking Break in the Exhibit Hall
10:30 AM — 11:45 AM Session 10 Track 1: Enhancing the Utilization of RIM with Emerging Use Cases
10:30 AM — 11:45 AM Session 10 Track 2: Cross-Industry Collaboration and Cross-Functional Integration of Data
10:30 AM — 10:30 AM Session 10 Track 3: CTD Structured Authoring and the Shift Away from Documents
10:30 AM — 11:45 AM Session 10 Track 4: Making Digital Transformation Real
11:45 AM — 1:15 PM Networking Luncheon in the Exhibit Hall
1:15 PM — 2:00 PM Session 11: FDA - Ask the Regulators
2:00 PM — 2:15 PM Closing Remarks
2:15 PM — 2:15 PM Forum Adjourns

Contact us

Registration Questions?

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1.888.257.6457

Preconference Short Courses

Regulatory Content and Submission Primer: Content from Authoring to Archive

Virtual Short Course: The Future of Documents Deep Dive into Structured Content

Virtual Short Course: Structured Data: IDMP is Not the Goal

Additional Information

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Regulatory Affairs and Submissions Resource Kit