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Regulatory Affairs and MRI Devices

Date: Saturday, 22nd June 2013 

Venue:  Room Number 121, Sir Alexander Fleming Building, Imperial College London, SW7 2AZ

Location: No 33 on the South Kensington Campus Map, available here. 

Workshop Aims:

Modern healthcare research is encountering new challenges from the regulatory bodies.

This course will give an overview of the regulatory landscape with clear definitions on the requirements and regulations for Medical Devices and Imaging Agents. The course will lay out the roadmap to take new methods into full scale clinical practice.  Roles and Responsibilities for different categories involved in research and development will be illustrated. 

The training course is meant to stimulate young researchers to think in new directions and to integrate new knowledge into their level of expertise.
 
Topics to be covered:
  • FDA approval and CE Marking for medical devices
  • MHRA approval for medical devices
  • Risk management for medical devices
  • GMP diagnostic imaging agent production
Programme: 

The complete workshop programme is available here.



Speakers:
 
Neil Ebeneze, MHRA
Philip Lartigue, GE
Alan Wenman, Medical Device Management
Simon Kinloch,GE
Peter Bradley, GE
Wadyslaw Gedroy, Imperial College London
Mihailo Ristic, Imperial College London
Jean Nehme, Touch Surgery
Andre Chow, Touch Surgery
Patricia Seifert, EPflex 
 
Organisers: 

Len Fass, GE Healthcare
Andreas Melzer, University of Dundee