Agenda
| Monday, 18 November 2019 | |
| 1.00 – 1.30 p.m. | Get together (incl. drinks & snacks) |
| 1.30 – 2.30 p.m. | Welcome Address1:30 Fai Ng: Introduction1:50 Emilio Merlo Pich / Stefan Avey: EFPIA perspective2:10 Walter Maetzler: Aims of the meeting & introduction to working groups |
| 2.30 – 4.00 p.m. | Discussion in four groupsA) Clinical assessmentAspects include: Feasibility study assessments, qualitative research, PSG subcohortB) Device criteriaAspects include: CE-certified devices, time period over which devices will be used, possible combinations of devicesC) Existing datasets & data platformsAspects include: Use of existing datasets for shaping the feasibility study and the clinical study, timeline of data platform creationD) Ethics, regulatory aspects & data protectionAspects 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 participants8.30 A) Clinical assessment9.00 B) Device criteria9.30 C) Existing datasets & data platforms10.00 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) |
