Agenda

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Day 1 Oct 12, 2023

10:00 AM — 2:00 PM

Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes

Day 2 Oct 13, 2023

10:00 AM — 2:00 PM

Short Course: Measuring the Quality of Real-World Data (RWD)

Day 3 Oct 16, 2023

7:30 AM — 5:30 PM

Conference Registration

7:30 AM — 8:30 AM

Networking Breakfast

8:30 AM — 8:45 AM

Opening Remarks

8:45 AM — 10:00 AM

Session 1: A Year in Review

10:00 AM — 10:45 AM

Refreshment and Networking Break

10:10 AM — 10:40 AM

Hosted Event/Non-CE: Case Study Spotlight Hosted by OM1: A New Era of Integrated Evidence Generation

10:45 AM — 12:00 PM

Session 2: Standardization of Real-World Data for Regulatory Submissions

12:00 PM — 1:00 PM

Networking Luncheon

1:00 PM — 2:15 PM

Session 3: Methodological Insights on External Controls and Sensitivity Analyses

2:25 PM — 3:40 PM

Session 4: “Tokenization”: Privacy-Preserving Data Integration to Enhance Clinical Trials and Real-World Evidence Studies

3:40 PM — 4:10 PM

Hosted Event/Non-CE: Case Study Spotlight hosted by Truveta: Using the EHR to identify Long COVID patients in near-real-time: A feasibility assessment of Truveta Data

3:40 PM — 4:10 PM

Refreshment and Networking Break

4:15 PM — 5:30 PM

Session 5: Case Studies from Recent Approvals of RWD/RWE Submissions

5:30 PM — 6:30 PM

Networking Reception sponsored by Merative

Day 4 Oct 17, 2023

7:15 AM — 4:10 PM

Conference Registration

7:15 AM — 8:00 AM

Networking Breakfast

7:30 AM — 8:00 AM

Hosted Event/Non-CE: Case Study Spotlight Sponsored by Clinetic: Accelerating Research Through Electronic Health Record (EHR) Surveillance

8:00 AM — 9:15 AM

Opening Remarks and Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making

9:20 AM — 10:35 AM

Session 7: Unexpected Issues in Pharmacoepidemiology Studies Applying Natural Language Processing to Clinical Notes

10:35 AM — 11:15 AM

Refreshment and Networking Break

10:40 AM — 11:10 AM

Hosted Event/Non-CE: Case Study Spotlight hosted by Purpose Life Sciences: RWE Integration by Design: An Essential Component of Early RCT Design

11:15 AM — 12:30 PM

Session 8: Cross-Industry Consortia Initiatives Addressing RWD Heterogeneity

12:30 PM — 1:30 PM

Networking Luncheon

1:30 PM — 2:45 PM

Session 9: Special Populations’ Perspectives on RWD and RWE

2:55 PM — 4:10 PM

Session 10: The Future of RWD and RWE

4:10 PM — 4:25 PM

Closing Remarks

4:25 PM — 4:25 PM

Conference Adjourns

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Real-World Evidence Conference

Agenda

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