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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 - 10:25 35 mins
Examining the Revisions to ISO 10993 – 1
  • Jeremy Tinkler - Director of Regulatory Consultancy and QA, MedPass International, France + Chairman of ISO/TC 194
  • The development of ISO 10993-1 – from controversy to consensus
  • Analysis of the current revision of ISO 10993-1
  • How will Notified Bodies react?
  • Current challenges and future possibilities
10:25 - 11:00 35 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

11:00 - 11:25 25 mins
Coffee & Networking Break
11:25 - 12:00 35 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
12:00 - 12:35 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.

12:35 - 14:05 90 mins
14:05 - 14:45 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
14:45 - 15:25 40 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
15:25 - 15:50 25 mins
Coffee & Networking Break
15:50 - 16:25 35 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)
16:25 - 17:00 35 mins
ISO 10993-4: Hemocompatibility Testing and the Use of an In-Vitro Loop
  • Kent Grove - Principal Biocompatibility Scientist, Abbott, USA
  • A review of hemocompatibility test selections under the revised ISO standard
  • Issues with the NAVI Model
  • Meet the in-vitro blood Loop
  • Overview of the Blood Loop Study Design 
  • FDA Feedback
  • Discussion of the Round Robin
  • Next steps and beyond
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