Agenda

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Day 1 Feb 02, 2026

10:00 AM — 5:05 PM

Forum Registration

11:30 AM — 12:30 PM

Networking Luncheon in the Exhibit Hall

12:30 PM — 1:00 PM

Welcoming Remarks and Presentation of the Excellence in Service Award

1:00 PM — 1:45 PM

Session 1: Opening Plenary - Achieving Regulatory Excellence: A Sponsor and Patient Perspective

1:50 PM — 3:05 PM

Session 2: FDA Electronic Submissions Update

3:05 PM — 3:50 PM

Refreshement and Networking Break in the Exhibit Hall

3:50 PM — 5:05 PM

Session 3: FDA - Ask the Regulators

5:05 PM — 6:05 PM

Networking Reception in the Exhibit Hall

Day 2 Feb 03, 2026

7:45 AM — 4:30 PM

Forum Registration

7:45 AM — 8:15 AM

Networking Breakfast in the Exhibit Hall

8:15 AM — 8:30 AM

Welcome to Day Two and DIA Community Update

8:30 AM — 10:00 AM

Session 4: eCTD 4.0 in Action: Readiness and Alignment Across Global Health Authorities

10:00 AM — 10:45 AM

Refreshment and Networking Break in the Exhibit Hall

10:45 AM — 12:00 PM

Session 5, Track 1: Enhancing Data Reliability and Acceptability of RWD to support Harmonized Regulatory Decision Making Across US, China and EU

10:45 AM — 12:00 PM

Session 5, Track 2: Successful Digital Implementation: Demystifying the Submissions Journey to Automation, AI & Data Content Transformation

10:45 AM — 12:00 PM

Session 5, Track 3: Has Cloud Innovation Stalled in Regulatory Exchange — And Why We Can’t Afford to Let It Stay That Way

10:45 AM — 12:00 PM

Session 5, Track 4: The Future of Regulatory: Reimagining Operating Models for the Digital and AI Revolution

12:00 PM — 1:15 PM

Networking Luncheon in the Exhibit Hall

1:15 PM — 2:30 PM

Session 6, Track 1: Shaping the Future of Regulatory: Trends, AI, and Practical Success

1:15 PM — 2:30 PM

Session 6, Track 2: Strategies to Transform Regulatory Affairs

1:15 PM — 2:30 PM

Session 6, Track 3: Drive Global Safety with Semantic Alignment: Implementing IDMP Ontology and FHIR for Smarter Pharmacovigilance

1:15 PM — 2:30 PM

Session 6, Track 4: Achieving Regulatory Operational Excellence: People, Process, Data, Tech

2:30 PM — 3:15 PM

Refreshement and Networking Break in the Exhibit Hall

3:15 PM — 4:45 PM

Session 7, Track 1: Data-driven Submissions - How Pharmaceutical Companies are Getting Ready for a New Era

3:15 PM — 4:45 PM

Session 7, Track 2: Interactive Workshop: Using Hackathons to Identify Regulatory Process Bottlenecks and Develop AI-Enabled Solutions

3:15 PM — 4:45 PM

Session 7, Track 3: Beyond Faster: Humans + AI and the Next Chapter of Regulatory Writing

3:15 PM — 4:45 PM

Session 7, Track 4: Leading Regulatory Transformation: Strategic Change, Data Innovation, and Human-Centered Leadership

Day 3 Feb 04, 2026

7:15 AM — 12:45 PM

Forum Registration

7:15 AM — 7:45 AM

Networking Breakfast in the Exhibit Hall

7:45 AM — 9:00 AM

Session 8, Track 1: Preparing for and Implementing eCTD 4.0 Implementation: Strategies, Challenges, and Lessons Learned

7:45 AM — 9:00 AM

Session 8, Track 2: Global Submissions Without Borders: Harmonizing Processes, Data, and Technology Across Diverse Health Authorities

7:45 AM — 9:00 AM

Session 8, Track 3: Industry Lessons Learned from FDA GenAI Community Challenge

7:45 AM — 9:00 AM

Session 8, Track 4: Co-Managing a Complete Regulatory Program with AI: A Sponsor–Technology Co-Design Case Study

9:10 AM — 10:25 AM

Session 9, Track 1: Federating the Forgotten: Content as a Data Asset in Your Enterprise Data Strategy

9:10 AM — 10:25 AM

Session 9, Track 2: Structured Content Implementations across the Drug Development Lifecycle

9:10 AM — 10:25 AM

Session 9, Track 3: Enabling Efficient Regulatory Submissions: A Cloud-Based Approach to Structured CMC Dossiers

9:10 AM — 10:25 AM

Session 9, Track 4: Cross-functional Collaboration: Integration Programs and Inspections

10:25 AM — 11:10 AM

Refreshment and Networking Break in the Exhibit Hall

11:10 AM — 12:30 PM

Session 10: Global Regulators in Focus: Key Updates Shaping the Future of Regulation

12:30 PM — 12:45 PM

Closing Remarks and Forum Adjourned

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