3rd Annual Medical Device Summer School
Downing College
Regent Street,
Cambridge , UK
 3rd Annual Medical Device Summer School 
Informa Ltd.

Schedule of Presentations:

Monday, September 7, 2009
07:30:00 Breakfast
08:15:00 Registration and coffee
08:45:00 Chairperson’s opening remarks Henry Sibun
08:50:00 Regulatory Affairs
09:00:00 Medical devices overview Henry Sibun
09:45:00 The role of European Industry Associations in influencing medical device regulation and related legislation Mike Kreuzer
10:15:00 Refreshment and networking break
10:45:00 Introduction to the Medical Device Directives John L Webster
11:30:00 Implications of the revisions to the MDD Jed Place
12:30:00 Lunch
13:25:00 Classification
13:30:00 Medical device classification Mika Reinkainen
14:00:00 Practical session: Classification Mika Reinkainen
14:45:00 Refreshment and networking break
14:50:00 Risk Management
15:15:00 Risk management strategies Adrian Keene
15:45:00 Practical session: Risk management strategies Adrian Keene
16:30:00 Chairperson’s closing remarks
16:45:00 Punting on the River Cam
19:30:00 Dinner
Tuesday, September 8, 2009
07:45:00 Breakfast
08:45:00 Chairperson’s opening remarks John L Webster
08:50:00 Research and Development
09:00:00 Researching new devices Mark O’Connell
09:45:00 Introduction to drug device combination products Alison Wilson
10:30:00 Refreshment and networking break
11:00:00 Device development John Rippeth
11:45:00 Sterilisation of medical devices: Options, validation and routine processing Sean Hanley
12:30:00 Lunch
13:30:00 The requirements and challenges for labelling medical devices Richard J Saunders
14:15:00 Operating in a quality management system Paul Sim
14:20:00 Clinical
14:45:00 Developing a clinical strategy Janette Benaddi
15:15:00 Refreshment and networking break
15:45:00 Ensuring biocompatibility of your device Adrian Keene
16:15:00 Legal
16:15:00 Practical session: Biocompatibility Adrian Keene
17:00:00 Review of patents and patenting medical devices Sinan Utku,
17:45:00 Chairperson’s closing remarks
18:00:00 Close of Day Two
19:30:00 Dinner
Wednesday, September 9, 2009
07:45:00 Breakfast
08:45:00 Chairperson’s opening remarks Sandy Geddes
08:50:00 Vigilance
09:00:00 Vigilance overview Sandy Geddes
09:45:00 Practical session: Vigilance Sandy Geddes
10:30:00 Refreshment and networking break
10:35:00 Marketing
11:00:00 Reimbursement: How to get technology paid for in the NHS Robert Dredge
11:45:00 Practical session: Reimbursement Robert Dredge
12:30:00 Lunch
14:00:00 Post-market surveillance of IVDs Judith Martin
14:05:00 Business Strategy
14:45:00 Case study presentation: Consumer diagnostics – moving into the home Sarah Johnson
15:30:00 Course round-up and Q&A session
15:45:00 Chairperson’s closing remarks
16:00:00 End of Day Three
3D Tissue Models
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