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Nov 28
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08:15 - 09:00 45 mins
09:00 - 09:10 10 mins
Chairperson’s Opening Remarks
  • Henry Sibun - Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for , TÜV SÜD Product Service GmbH, UK
09:10 - 09:50 40 mins
Panel Session: A Review of the Recent Changes to ISO 10993
  • Sherry P. Parker, Ph.D. - Toxicology Director, Fresenius Medical Care + TC/194 Working Group, USA
  • Albrecht Poth - Senior Toxicologist, Knoell Germany GmbH + TC/194 Working Group, Germany
  • Theodore Heise, Ph.D., RAC - VP Regulatory and Clinical Services, MED Institute, USA
  • What’s changed? – the presentation and discussion of recent revisions
  • What’s coming? – a summary and status update of standards under development
  • Justifying the need for these changes: moving towards a risk based approach
09:50 - 10:20 30 mins
Examining the Revisions to ISO 10993 – 1
  • Jeremy Tinkler - Director of Regulatory Consultancy and QA, MedPass International, France + Chairman of ISO/TC 194
  • An in-depth analysis of the recent revisions to Part 1
  • How the changes effect device classification and biocompatibility testing
  • Notified body guidance on implementation preparation
10:20 - 10:50 30 mins
Changes in Biocompatibility Requirements: MDD to MDR
  • Henry Sibun - Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for , TÜV SÜD Product Service GmbH, UK
  • Discussing the differences between the Directive and the Regulation
  • How will these changes effect biocompatibility assessments for new devices?
  • The impact of the General Safety and Performance Requirements
  • An implementation timeline for devices already on the market

10:50 - 11:20 30 mins
Coffee & Networking Break
11:20 - 11:55 35 mins
Successfully Implementing ISO 10993-4
  • An in-depth review of hemocompatibility testing under revised ISO standard
  • Determining appropriate chemical characterisation tests for devices with blood interaction
  • Frequent challenges and advice for overcoming them
11:55 - 12:30 35 mins
The Threshold of Toxicological Concern (TTC) – A valuable tool in ISO 10993-17 health risk assessments
  • Pete Watts - Toxicology Director, bibra toxicology advice & consulting, UK

Practical aspects preclude comprehensive testing of the infinite universe of chemicals. The TTC concept offers a pragmatic and health-precautionary solution to the challenge of assessing the possible health risks associated with exposure to untested or inadequately tested E/Ls, when suitable tested “read-across” analogues cannot be identified. TTC can also be applied, with appropriate structural assumptions, to unidentified E/Ls.

12:30 - 14:00 90 mins
14:00 - 14:30 30 mins
Part 18: Practically Applying the Chemical Characterisation Approach
  • Theodore Heise, Ph.D., RAC - VP Regulatory and Clinical Services, MED Institute, USA
  • Examining the revisions to ISO 10993-18
  • Chemical characterization testing strategies for biocompatibility submission documents
  • Analysing the data and what it means for your risk assessment
  • Case studies on chemical characterisation pitfalls and lessons learned
  • A discussion on the costs and benefits
14:30 - 15:10 40 mins
Determining Toxicological Risk Based on Extractables and Leachables Data
  • Philippe Hasgall - Principal Scientist Biology, Zimmer Biomet, Switzerland
  • Practical advice for designing an extractable leachable study
  • Discussing the relevance of extraction condition to new applications
  • Examining the findings and assessing the risk of the test results
15:10 - 15:40 30 mins
Guidance on Nanomaterials
  • Lars Magnus Bjursten - Professor Bioimplant Research, Convener for the Swedish TC194 – 10993 Series, Lund University + TC/194 Working Group, Sweden
  • An introduction to the nanomaterials TR
  • Clarification of acceptable tests based on ISO 10993
  • Case study on nanoparticle standard-test scenarios for medical device biocompatibility
  • What is needed when using nanomaterials both a particulates and as solid materials (composites and surface modification)
15:40 - 16:00 20 mins
Coffee & Networking Break
16:00 - 16:30 30 mins
Material and Manufacturing Equivalence in Medical Devices
  • Dr. James Moore, Ph.D. - Senior Scientist, Biocompatibility, W.L. Gore & Associates Inc., USA
  • Evaluations for material and manufacturing equivalence
  • What does "identical" mean when rationalizing equivalence?
  • Challenges for proving equivalence
16:30 - 17:00 30 mins
Biocompatibility and Wound Healing
17:00 - 17:20 20 mins
End of Day 1
17:20 - 17:30 10 mins
Move to Plenary Room
17:30 - 17:35 5 mins
Opening remarks from the Chairperson – Plenary Talk