Agenda

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Day 1 Apr 03, 2025

10:00 AM — 2:00 PM

Global Labeling – The Basics of Core Datasheet

Day 2 Apr 07, 2025

7:30 AM — 5:35 PM

Meeting Registration

7:30 AM — 8:15 AM

Networking Breakfast

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 10:00 AM

Session 1: Last One Mile for e-labeling: Accelerating Health Innovation with e-labeling and Healthcare Interoperability

10:00 AM — 10:45 AM

Refreshments, Exhibits, and Networking Break

10:05 AM — 10:35 AM

Hosted Session/Non-CE: Case Study Spotlight by Dr. Evidence

10:45 AM — 12:00 PM

Session 2: Patient Centric Labeling for Shared Decision-making in Healthcare

12:00 PM — 1:00 PM

Luncheon, Exhibits, and Networking Break

1:00 PM — 2:15 PM

Session 3: Ensuring Excellence in Safety Labeling: Strategies, Collaboration, and Global Best Practices

2:15 PM — 3:00 PM

Refreshments, Exhibits, and Networking Break

2:20 PM — 2:50 PM

Hosted Session/Non-CE: Case Study Spotlight by Glemser: Structured Content AI and ePI Conversions

3:00 PM — 4:15 PM

Session 4: End-to-End (E2) Labeling Process, Concepts, and Initiatives

4:20 PM — 5:35 PM

Session 5: Packaging Label Insights

5:35 PM — 6:35 PM

Networking Reception

Day 3 Apr 08, 2025

7:30 AM — 3:45 PM

Meeting Registration

7:30 AM — 8:15 AM

Networking Breakfast

8:15 AM — 9:30 AM

Session 6: Professional Development for Labeling: Building Skills for Cross-Functional and Digital Success

9:30 AM — 10:15 AM

Refreshments, Exhibits, and Networking Break

9:35 AM — 10:05 AM

Hosted Session/Non-CE: Case Study Spotlight by Basil Systems: Unleash Oncology: Fast-Track Market Access with Unified Labeling

10:15 AM — 11:30 AM

Session 7: Human Factors Testing to Core Device Label - Case Study

11:30 AM — 12:30 PM

Luncheon, Exhibits, and Networking Break

12:30 PM — 1:45 PM

Session 8: Will Artificial Intelligence (AI) Transform Drug Labeling Processes?

1:45 PM — 2:30 PM

Refreshments, Exhibits, and Networking Break

2:30 PM — 3:30 PM

Session 9: Rare Diseases: Cell and Gene Therapy Labeling Requirements and Considerations

3:30 PM — 3:45 PM

Closing Remarks

3:45 PM — 3:45 PM

Conference Adjourns

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