Agenda

Day 1 Oct 24, 2019

8:00 AM — 8:30 AM

Registration

8:30 AM — 9:10 AM

The Impact of Digital Technologies in Health

9:15 AM — 10:45 AM

10:45 AM — 11:00 AM

Coffee Break

11:00 AM — 12:30 PM

Session 2: Parallel Scientific Advice

12:30 PM — 2:00 PM

Lunch

2:00 PM — 3:30 PM

Session 3: Parallel Scientific Advice & Early Dialogue - Role Play on Mini Scientific Parallel Advice

3:30 PM — 4:00 PM

Coffee Break

4:00 PM — 5:30 PM

Session 4: Post Licensing Evidence Generation – What Is It and What Is Its Purpose?

5:30 PM — 7:00 PM

Networking Reception sponsored by Clinerion

Day 2 Oct 25, 2019

8:00 AM — 8:30 AM

Registration

8:30 AM — 10:00 AM

Session 5: Post-Launch Evidence Generation (PLEG) – Workshop

10:00 AM — 10:30 AM

Coffee Break

10:30 AM — 12:00 PM

Session 6: Joint Clinical Assessment (REA)

12:00 PM — 1:00 PM

Lunch

1:00 PM — 2:30 PM

Session 7: Joint Clinical Assessment (REA) Workshop

2:30 PM — 3:00 PM

Coffee Break

3:00 PM — 4:15 PM

Session 8: Suitability of Current Regulatory and HTA Frameworks for New High Value Curative Technologies

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Value, Access & Regulatory Evidence Workshop