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Bethesda North Marriott Hotel and Conference Center

03 feb 2025 7:45 a.m. - 05 feb 2025 12:45 p.m.

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

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Agenda

Print Agenda

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

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

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