Agenda

Día 1 10 feb 2026

8:00 AM — 9:15 AM

Session 8, Track 1: Global harmonization and Reality: Navigating eCTD v4 Pilots in Key Markets

8:00 AM — 9:15 AM

Session 8, Track 2:

8:00 AM — 8:15 AM

Session 8, Track 3: Selecting Fit-for-Purpose Regulatory AI

8:00 AM — 9:15 AM

Session 8, Track 4: Achieving an Effective Regulatory KPI / Metrics Program

9:25 AM — 10:40 AM

Session 9, Track 1: Building an AI-Ready Regulatory Data Foundation: How Data Products, Dimensional Models, and Semantic Layers Enable Trusted Data

9:25 AM — 10:40 AM

Session 9, Track 2: From Fire Drills to Frameworks: Realizing the Value of Regulatory Investments

9:25 AM — 10:40 AM

Session 9, Track 3: From Legacy Content to Trusted, Interoperable Regulatory Exchange

9:25 AM — 10:40 AM

Session 9, Track 4: Evolution in Action: Regulatory Operations as the Bridge to Data and Digital Transformation

11:15 AM — 12:30 PM

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

Día 2 08 feb 2027

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

1:50 PM — 3:05 PM

Session 2: FDA – Electronic Submissions

3:05 PM — 3:50 PM

Refreshment and Networking Break in the Exhibit Hall

3:50 PM — 5:00 PM

Session 3: FDA – Ask the Regulators

5:00 PM — 6:00 PM

Networking Reception in the Exhibit Hall

Día 3 09 feb 2027

7:45 AM — 4:30 PM

Forum Registration

8:30 AM — 10:00 AM

Session 4: FDA - Demonstration Projects under PDUFA VII to Leverage Cloud Technologies to Improve FDA – Industry Communication

10:45 AM — 12:00 PM

Session 5, Track 1: Structured Content, Smarter AI: Taming the Rising Cost of GenAI in Regulatory Operations

10:45 AM — 11:59 AM

Session 5, Track 2: Measure What Matters: Build the Visibility Needed to Improve Regulatory Performance

10:45 AM — 12:00 PM

Session 5, Track 3: Selecting, Scaling, Measuring, and Governing Regulatory AI

10:45 AM — 12:00 PM

Session 5, Track 4: When Technology Stops Being the Constraint: Leadership and Organizational Readiness for the Next Era of Regulatory Execution

1:11 PM — 2:30 PM

Session 6, Track 3: AI-enabled Clinical Data Workflows from Pilot to Practice

1:15 PM — 2:30 PM

Session 6, Track 1: Inspection-Ready by Design: What an AI-Authored Document Must Prove Three Years Later

1:15 PM — 2:30 PM

Session 6, Track 2: Building Bridges, Not Bottlenecks: Advancing Regulatory Agility Through Coordination, Dialogue, and Reliance

1:15 PM — 2:30 PM

Session 6, Track 4: Enabling Small & Mid-Sized Pharmaceutical Companies to Leverage Reliance Pathways, Data-Driven Decision Making, and AI

3:15 PM — 4:45 PM

Session 7, Track 1: Beyond the PDF: How Digital Protocols, ICH M11, and USDM Can Accelerate Regulatory Review

3:15 PM — 4:45 PM

Session 7, Track 2: The Edit Room: Regulatory Execution Excellence Forum

3:15 PM — 4:45 PM

Session 7, Track 3: FHIR-Based ePI: From Process and Creation to Patient Distribution

3:15 PM — 4:45 PM

Session 7, Track 4: Beyond Documents: Designing the Future of Regulatory Data Collaboration

Día 4 10 feb 2027

7:15 AM — 12:45 PM

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