ESC Premium Access

Approval processes for medical devices - Understanding clinical and regulatory perspectives - Spotlight on coronary stents

Event: ESC CONGRESS 2017
Topic: Public health and health policy
Session type: Symposium
Date: 28 August 2017
Time: 11:00 - 12:30


6 presentations in this session

The regulatory landscape in Europe: challenges and opportunities of the new EU Medical Devices Regulation

Speaker: Professor A. Fraser (Cardiff, GB)

Developing device-specific common standards in Europe. The regulators' perspective

Speaker: Mr C. Griesinger (Ispra, IT)

Clinical evaluation of coronary stents and bio-resorbable stents: ESC/EAPCI engagement with the EU regulatory system

Speaker: Professor R. Byrne (Dublin, IE)

Marketing of medical devices in the US & Europe: focus on regulatory requirements and patient access

Speaker: Professor R. Waksman (Washington, DC, US)

EU cooperation on HTA: where are we and where do we want to go

Speaker: Professor P. Szymanski (Warszawa, PL)

Panel discussion: device regulation


5 speakers from this session

Professor Alan Fraser

University Hospital of Wales, Cardiff (United Kingdom of Great Britain & Northern Ireland)
15 presentations
1 follower

Mr Claudius Griesinger

, Ispra (Italy)
1 presentation
0 follower

Professor Robert Byrne

Mater Private Hospital, Dublin (Ireland)
14 presentations
1 follower

Professor Ron Waksman

Medstar Washington Hospital Centre, Washington, DC (United States of America)
3 presentations
0 follower

Professor Piotr Szymanski

CSK MSWiA, Warszawa (Poland)
4 presentations
0 follower

This platform is supported by

logo Novo Nordisk