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BOSTON, USA (British Consulate):
Tuesday 3rd October
0830 Registration & Exhibition
0900 Opening Address - Roy Lilley (conference Chairman)
0915 How we arrived, where we are and what the future may hold – tomorrow’s global medical device regulation. Alan Kent, former Chief Executive of the MDA and former member of the Global Harmonisation Task Force (GHTF).
0945 The Recast of the Medical Device Directives - problems and solutions? Trevor Lewis, Medical Device Consultancy.
1015 Clinical Evaluation – what it is and how it should be done. Dr. Pete Wall, Isca Healthcare Research.
1045 Morning Break & Exhibition
1100 What is the view of the European medtech industry? John Wilkinson, Chief Executive, Eucomed.
1130 The In Vitro view, what the Recast means for diagnostics and why IVDs are key to the future of healthcare. Doris-Ann Williams, Chief Executive, BIVDA.
1200 Panel Discussion Q&A - Chaired by Roy Lilley and including Susanne Ludgate, Medical Director of Devices, Medicines & Healthcare Regulatory Authority (UK).
1230 Lunch & Exhibition
1330 Case Study 1: Working with the Recast for IVDs, Speaker TBA.
1350 Case Study 2: Working with the Recast for Medical Devices, Speaker TBA.
1700 Conference close.
Tuesday 3rd October
0830 Registration & Exhibition
0900 Opening Address - Roy Lilley (conference Chairman)
0915 How we arrived, where we are and what the future may hold – tomorrow’s global medical device regulation. Alan Kent, former Chief Executive of the MDA and former member of the Global Harmonisation Task Force (GHTF).
0945 The Recast of the Medical Device Directives - problems and solutions? Trevor Lewis, Medical Device Consultancy.
1015 Clinical Evaluation – what it is and how it should be done. Dr. Pete Wall, Isca Healthcare Research.
1045 Morning Break & Exhibition
1100 What is the view of the European medtech industry? John Wilkinson, Chief Executive, Eucomed.
1130 The In Vitro view, what the Recast means for diagnostics and why IVDs are key to the future of healthcare. Doris-Ann Williams, Chief Executive, BIVDA.
1200 Panel Discussion Q&A - Chaired by Roy Lilley and including Susanne Ludgate, Medical Director of Devices, Medicines & Healthcare Regulatory Authority (UK).
1230 Lunch & Exhibition
1330 Case Study 1: Working with the Recast for IVDs, Speaker TBA.
1350 Case Study 2: Working with the Recast for Medical Devices, Speaker TBA.
1410 Case Study 3: Working with the
Recast for Support Services, Speaker TBA.
1430 Panel Discussion Q&A, chaired by
Roy Lilley
1500 What is expected from devices that get recommended for
use in the UK NHS? Mirella Marlow, NICE
1600 Recast next steps for medical device manufacturers in the EU. Gert
Bos, Head of Regulatory and Clinical Affairs Healthcare, BSI.
1630 Open Discussion
- what should be in your re-cast toolkit? Everything you need to organise & manage the transition. Chaired by Roy
Lilley
1700 Conference close.
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