Agenda

Day 1 Oct 19, 2026

7:30 AM — 5:00 PM

Conference Registration

7:30 AM — 8:30 AM

Networking Breakfast

8:30 AM — 8:45 AM

Welcome and Opening Remarks

8:45 AM — 10:00 AM

Session 1: RWE Regulatory Update: Perspectives from Around the Globe

10:00 AM — 10:45 AM

Refreshment and Networking Break

10:10 AM — 10:40 AM

Hosted Session/Non-CE: Case Study hosted by

10:45 AM — 12:00 PM

Session 2: From Negative Controls to Novel Designs: Strengthening Clinical Development with Real-World Data and Evidence

12:00 PM — 1:00 PM

Networking Luncheon

1:00 PM — 2:15 PM

Session 3: Design Scalable RWD Infrastructure: Integrate Multimodal Data and Standards for Efficient RWE Generation

2:20 PM — 3:35 PM

Session 4: Innovative Approaches and Considerations for Use of External Controls in Drug Development

3:35 PM — 4:10 PM

Refreshment and Networking Break

3:40 PM — 4:10 PM

Hosted Case Study

4:10 PM — 5:25 PM

Session 5: The Economics of RWD and RWE: How to Estimate and Maximize Return on Investment

5:25 PM — 6:30 PM

Networking Reception

Day 2 Oct 20, 2026

7:45 AM — 5:00 PM

Conference Registration

7:45 AM — 8:30 AM

Networking Breakfast

8:30 AM — 9:15 AM

Opening Remarks and Session 6: A 10 year Retrospective on RWE since the 21st Century Cures Act

9:15 AM — 10:30 AM

Session 7: Open Regulatory Intelligence: A Deep Dive Into Strategies, Data, Tools, Insights, and Best Practices

10:30 AM — 11:15 AM

Refreshment and Networking Break

10:45 AM — 11:15 AM

Hosted Case Study

11:15 AM — 12:30 PM

Session 8: Translate RWD into Decision-Ready for HTA and Market Access

12:30 PM — 1:45 PM

Networking Luncheon

1:10 PM — 1:40 PM

Hosted Case Study

1:45 PM — 3:00 PM

Session 9: Building AI and Machine Learning Innovations for Credible Real-World Evidence Generation

3:00 PM — 4:15 PM

Session 10: Unlock the Future of RWE: Shaping the Next Era of Regulatory-Grade RWE

4:10 PM — 4:30 PM

Closing Remarks

4:30 PM — 4:30 PM

Conference Adjourns

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