Agenda

Day 1 Nov 15, 2023

1:00 PM — 1:15 PM

Participants Log-in and Connect

1:15 PM — 1:30 PM

Welcome and Introduction by DIA

1:30 PM — 2:00 PM

Opening Keynote

2:00 PM — 3:10 PM

Session 1: Requirements and Opportunities for Innovation in Clinical Trials in Europe: Navigating the Legislation Landscape

3:10 PM — 3:25 PM

Coffee Break

3:25 PM — 4:35 PM

Session 2: Platform Trials in Europe: EU PEARL Project and the ACT EU Vision

4:35 PM — 4:45 PM

Coffee Break

4:45 PM — 5:55 PM

Session 3: Part I: Real-World Evidence in Regulatory and HTA Decision Making: Report on MetReal Cluster covering 5 European Horizon Europe Projects

5:55 PM — 6:10 PM

Recap of the Day

Day 2 Nov 16, 2023

1:30 PM — 1:40 PM

Welcome and Introduction by DIA

1:40 PM — 2:40 PM

Session 4: Digital Health Technologies in Clinical Trials: Update on the State of Play: Decentralized Clinical Trials

2:40 PM — 2:50 PM

Coffee Break

2:50 PM — 4:00 PM

Session 5: Leveraging Artificial Intelligence (AI) In Clinical Trials - Opportunities and Ethical Considerations

4:00 PM — 4:10 PM

Coffee Break

4:10 PM — 5:10 PM

Session 6: Leveraging Artificial Intelligence (AI) In Clinical Trials - Regulatory Perspectives

5:10 PM — 5:20 PM

Coffee Break

5:20 PM — 6:30 PM

Session 7: Part II: Real-World Evidence in Regulatory and HTA Decision-Making: Global and Regional Perspectives on Moving from Pilots to Operation

6:30 PM — 6:40 PM

Closing words and key take-aways

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