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Webinar: Time for a Change: Evidence-Based Approaches for the Biological Safety Assessment of Medical Devices

12 June, 2023 @ 16:00 - 17:00

Join this free webinar where Ron Brown, toxicologist and former FDA risk assessor, will outline the need for a new and more agile approach for the biological safety assessment of medical devices.

This presentation will identify the limitations associated with the current approach, which largely relies on animal-based tests that may have questionable clinical relevance. It will also describe how new and existing biocompatibility test methods can be evaluated following the principles of an evidence-based toxicology (EBT).

You will also learn how to incorporate New Approach Methodologies (NAMs) into a streamlined workflow for the safety assessment of medical devices, which may decrease the time needed for regulatory approval of a device.

Key takeaways

  • The limitations associated with animal-based approaches used to assess the biological safety of medical devices.
  • How to assess the validity of NAMs by using an evidence-based toxicology (EBT) approach.
  • How to incorporate NAMs into a streamlined workflow for medical device safety assessment.
  • A case study on the OECD approval of the in vitro assay GARDskin and its applicability for Medical Device assessments supporting both polar and non-polar extraction vehicles (ISO 10993-12).

Speakers

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Details

Date:
12 June, 2023
Time:
16:00 - 17:00
Event Category:

Details

Date:
12 June, 2023
Time:
16:00 - 17:00
Event Category: