25th March 2025 | 10:00am EDT / 7:00am PDT / 2:00pm GMT / 3:00pm CET | Ron Brown, Toxicologist at Risk Science Consortium |BOOK FREE SEAT FOR THIS WEBINAR
The toxicological risk assessment of E&L compounds is typically conducted on a compound-by-compound basis; however, for compounds that lack toxicity data, it may be useful to group compounds together that have similar structural and physical-chemical properties, as
well as a similar toxicological mechanism of action, to derive a class-specific Tolerable Intake (TI) or Permitted Daily Exposure (PDE) that is applicable for all compounds in that group. This talk explores ways to group compounds based on their structural and toxicological
similarity and how to use computational models to identify a proposed toxicological mechanism of action for compounds in a group. The presentation will also review methods to conduct a cumulative risk assessment of the
compounds in the assembled group. This approach of first assembling a group of compounds with a common toxicological mechanism, then conducting a risk toxicological assessment of the compounds in the group, has the potential to streamline the toxicological risk assessment
process when large numbers of extractable or leachable compounds are released from a polymeric material and provides a science-based method for setting TI/PDE values that is presumably less conservative than the use of Threshold of Toxicological Concern (TTC) values as default TI/PDE values for the individual compounds
Presented by Ron Brown, Toxicologist at Risk Science Consortium

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is a founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk.
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