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Leachables sensitisation assessment framework in collaboration with ELSIE

This enlightening event brought together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitisation potential of extractables and leachables (E&Ls).

Featured presenters and ELSIE consortium members included:

  • Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer
  • Geraldine Whelan, Regulatory Toxicologist at GSK
  • Martyn Chilton, Principal Scientist at Lhasa Limited

Established in 2007, the ELSIE Consortium unites pharmaceutical, biotechnology, and medical device companies with a shared vision of becoming the leading industry voice and scientific resource on E&Ls.
This exciting webinar entailed:

  1. Introduction and background:
    • Uncover the essence of E&Ls
    • Explore their origins and sources
    • Understand the traditional risk assessment methodologies

  2. ELSIE sensitisation framework overview:
    • Delve into the ELSIE sensitisation assessment framework
    • Explore different routes of administration: dermal, respiratory, parenteral

  3. Analysis of ELSIE/Product Quality Research Institute (PQRI) databases:
    • Constructing a comprehensive database
    • Expert review of qualitative sensitisation data
    • Prevalence of strong/extreme sensitizers
    • Search for and prediction of quantitative sensitisation data
    • Plotting quantitative data against established safety thresholds

  4. Case studies:
    • Illustrative case studies for each route of administration: dermal, respiratory, parenteral