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

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