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Monday, 18 November 2019
1.00 – 1.30 p.m. Get together (incl. drinks & snacks)
1.30 – 2.30 p.m. Welcome Address

1:30 Fai Ng: Introduction

1:50 Emilio Merlo Pich / Stefan Avey: EFPIA perspective

2:10 Walter Maetzler: Aims of the meeting & introduction to working groups

2.30 – 4.00 p.m. Discussion in four groups

A) Clinical assessment

Aspects include: Feasibility study assessments, qualitative research, PSG subcohort

B) Device criteria

Aspects include: CE-certified devices, time period over which devices will be used, possible combinations of devices

C) Existing datasets & data platforms

Aspects include: Use of existing datasets for shaping the feasibility study and the clinical study, timeline of data platform creation

D) Ethics, regulatory aspects & data protection

Aspects include: Feasibility of timeline for ethics submission, ethical considerations for clinical assessments, regulatory considerations including efforts to keep the study “observational” rather than a “device-study” (MHRA approval would slow down the project)

4.00 – 4.30 p.m. Coffee break
4.30 – 6.00 p.m. Collection of results from discussion in four groups
(for presentation on Tuesday)
Tuesday, 19 November 2019
8.30 –10.30 a.m. Presentation & discussion of group results with all participants

8.30     A) Clinical assessment

9.00     B) Device criteria

9.30     C) Existing datasets & data platforms

10.00   D) Ethics & data protection

10.30 – 11.00 a.m. Coffee break
11.00 – 12.00 a.m. From Vision to Practice: the first 18 months of IDEA-FAST (including logistics of running the studies)
12.30 – 1.00 p.m. Summary and Farewell (Fai Ng)
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