会议日程

天 1 2025 年 02 月 03 日

10:00 AM — 5:00 PM

Forum Registration

11:30 AM — 12:30 PM

Networking Luncheon in the Exhibit Hall

12:30 PM — 12:55 PM

Welcoming Remarks and Presentation of the Excellence in Service Award

12:55 PM — 1:40 PM

Session 1: Keynote Address - Managing Change in a time of Regulatory Transformation

1:45 PM — 3:00 PM

Session 2: FDA Plenary - Global IDMP Implementation – Getting Closer to the Goal

3:00 PM — 3:45 PM

Refreshment and Networking Break in the Exhibit Hall

3:05 PM — 3:35 PM

Hosted Session/Non-CE: Case Study Sponsored by DNAnexus

3:45 PM — 5:15 PM

Session 3: FDA Plenary: Data and Technology Strategy

5:15 PM — 6:15 PM

Networking Reception in the Exhibit Hall

天 2 2025 年 02 月 04 日

7:45 AM — 8:15 AM

Networking Breakfast in the Exhibit Hall

7:45 AM — 5:00 PM

Registration

8:15 AM — 8:30 PM

Welcome to Day Two and DIA Community Update

8:30 AM — 10:00 AM

Session 4: FDA Plenary: Electronic Submissions Update

10:00 AM — 10:45 AM

Refreshment and Networking Break in the Exhibit Hall

10:05 AM — 10:35 AM

Hosted Session/Non-CE: Case Study Sponsored by Weave AI

10:45 AM — 12:00 PM

Session 5, Track 1: A Framework for Decision-making for Regulatory Information Management and Operations Leaders

10:45 AM — 12:00 PM

Session 5, Track 2: Igniting Seamless Data Flow: Enhancing Business Processes and Governance with FHIR and ICH Innovations

10:45 AM — 12:00 PM

Session 5, Track 3: How to Avoid AI Overload: Navigating Impactful Applications Today and Tomorrow

10:45 AM — 12:00 PM

Session 5, Track 4: Enhancing Regulatory Submissions and Interactive Communication: Insights from PRISM

12:00 PM — 1:15 PM

Networking Luncheon in the Exhibit Hall

1:15 PM — 2:30 PM

Session 6, Track 1: DIA RIM Reference Model V2.0 catches FHIR!

1:15 PM — 2:30 PM

Session 6, Track 2: Driving Value from Regulatory Intelligence – A Multi-disciplinary Approach

1:15 PM — 2:30 PM

Session 6, Track 3: How to Make the Most of an Evolving Tech Landscape Crowded with Competing Solutions: Survival of the Fittest vs Symbiosis?

1:15 PM — 2:30 PM

Session 6, Track 4: Is a Single Dossier Really Possible? Attainable Technological and Regulatory Advancements Toward Global Dossier Harmonization

2:30 PM — 3:15 PM

Refreshment and Networking Break in the Exhibit Hall

2:35 PM — 3:05 PM

Hosted Session/Non-CE: Case Study Sponsored by InteliNotion: Harnessing GenAI in a Global Biopharmaceuticals Company

3:15 PM — 4:30 PM

Session 7, Track 1: Common Pain Points Surrounding Regulatory Submissions

3:15 PM — 4:30 PM

Session 7, Track 2: Towards Instantaneous Approvals in 5 years: What Would it Take to Get There?

3:15 PM — 4:30 PM

Session 7, Track 3: ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force to Reduce Regulatory Complexity and Accelerate Patient Access

3:15 PM — 4:30 PM

Session 7, Track 4: Transforming Regulatory Submissions with Advanced Data Management and Global Strategies

天 3 2025 年 02 月 05 日

7:30 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

7:30 AM — 12:30 PM

Registration

8:00 AM — 9:15 AM

Session 8, Track 1: Regulatory Submission Revolution: Insights into eCTD 4.0, Agile Governance & AI-Driven Document Migration

8:00 AM — 9:15 AM

Session 8, Track 2: Automated Authoring: The Perfect Harmony of SCA and Gen AI

8:00 AM — 9:15 AM

Session 8, Track 3: Implementing Innovation Successfully via Robust Data Standards

8:00 AM — 9:15 AM

Session, 8 Track 4: Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era

9:25 AM — 10:40 AM

Session 9, Track 1: Gaining Efficiency: Using Automation across Writing, Hyperlinking, and Rendering

9:25 AM — 10:40 AM

Session 9, Track 2: Optimizing Marketing Application Timelines: Insights and Strategies for Transitioning to eCTD 4.0

9:25 AM — 10:40 AM

Session 9, Track 3: Strategic Innovation in Regulatory: Advancing Technology and Its Impact on Submissions

9:25 AM — 10:40 AM

Session 9, Track 4: Not Business as Usual: How to modernize Your Regulatory Operations for Today’s VC and AI-fueled Pharma Market

10:40 AM — 11:20 AM

Refreshment and Networking Break in the Exhibit Hall

10:45 AM — 11:15 AM

Hosted Session/Non-CE: Case Study Sponsored by Astrix

11:20 AM — 12:35 PM

Session 10: International Regulatory Authority Updates

12:35 PM — 12:45 PM

Closing Remarks

12:45 PM — 12:45 PM

Forum Adjourns

Regulatory Submissions, Information, and Document Management Forum

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