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09:00 - 10:00 60 mins
Main agenda
Biocompatibility the Basics: Pre-Conference Workshop Registration
10:00 - 10:20 20 mins
Main agenda
Introduction – speakers and workshop participants
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
  • Alice Ravizza - CEO, PGG consulting
more
10:20 - 10:35 15 mins
Main agenda
What is Biocompatibility?
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more
  • What is Biocompatibility?
  • How does it related to essential requirements for regulatory compliance?
10:35 - 10:50 15 mins
Main agenda
Explaining the ISO 10993 series
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
more
  • Explaining the ISO 10993
  • Discussing the different working groups
  • An overview of what the over groups do 
10:50 - 11:05 15 mins
Main agenda
Morning Break
11:05 - 11:20 15 mins
Main agenda
Why is biocompatibility important?
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more
  • Why Biocompatibility is important
  • Biocompatibility vs Biological Evaluation
11:20 - 11:35 15 mins
Main agenda
The risk management approach to Biocompatibilty
  • Alice Ravizza - CEO, PGG consulting
more
  • The relationship between ISO 10993,
  •  ISO 13485, 
  • ISO 14971 
  • ISO TR 15499, 
  • Other ISO standards related to biocompatibility
12:00 - 12:15 15 mins
Main agenda
GLP
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more
  • History
  • Why is it important for biocompatibility studies?
  •  Do I need it for my studies?
12:15 - 12:30 15 mins
Main agenda
Interactive Session: Design a biocompatibility testing strategy for a medical device
12:30 - 13:30 60 mins
Main agenda
Lunch & networking break
13:30 - 14:15 45 mins
Main agenda
Chemical characterisation and other tools
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
more
14:15 - 14:30 15 mins
Main agenda
Biocompatibility study costs
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
more
14:30 - 14:45 15 mins
Main agenda
Break
14:45 - 15:00 15 mins
Main agenda
Change management
  • Alice Ravizza - CEO, PGG consulting
more
15:00 - 15:20 20 mins
Main agenda
How changes can affect biocompatibility
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more
15:20 - 15:40 20 mins
Main agenda
Interactive Exercise – biocompatibility and change management
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more
15:40 - 16:00 20 mins
Main agenda
Q+A Session
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
  • Alice Ravizza - CEO, PGG consulting
  • Philip Clay - Director and principal toxicologist, Chorley Consulting Ltd.
more