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Informa
Nov 27
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09:00 - 10:00 60 mins
Registration Pre-Conference Workshop
10:00 - 10:10 10 mins
Workshop Introductions
  • Albrecht Poth - Senior Toxicologist, Knoell Germany GmbH + TC/194 Working Group, Germany
  • Dr. James Moore, Ph.D. - Senior Scientist, Biocompatibility, W.L. Gore & Associates Inc., USA
10:10 - 10:20 10 mins
An Introduction to Biocompatibility
10:20 - 10:30 10 mins
Risk Management: Understanding ISO 14971
10:30 - 11:00 30 mins
Info
ISO 10993 Series – Comprehensive Coverage

 

11:00 - 11:25 25 mins
Coffee & Networking Break
11:25 - 11:45 20 mins
Exploring the Device Classification System in the EU & US
11:45 - 12:05 20 mins
The Importance of Chemical Characterisation
12:05 - 12:30 25 mins
Designing a Risk Based Approach
12:30 - 13:45 75 mins
Lunch
13:45 - 15:15 90 mins
Interactive Session: Toxicological Risk Assessments
15:15 - 15:35 20 mins
Coffee & Networking Break
15:35 - 15:55 20 mins
Change Management and Handling Failures
15:55 - 16:15 20 mins
Q+A Session
16:15 - 16:20 5 mins
End of Pre-Conference Workshop