Join us for our upcoming webinar ‘Leachables sensitisation assessment framework in collaboration with ELSIE’.
This enlightening, pre-recorded event will bring together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitization potential of extractables and leachables (E&Ls).
Featured presenters and ELSIE consortium members will include:
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.
Webinar agenda:
Introduction and background:
• Uncover the essence of E&Ls
• Explore their origins and sources
• Understand the traditional risk assessment methodologies
ELSIE sensitisation framework overview:
• Delve into the ELSIE sensitisation assessment framework
• Explore different routes of administration: dermal, respiratory, parenteral
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
Case studies:
• Illustrative case studies for each route of administration: dermal, respiratory, parenteral
Delegates require an internet connection and either a telephone or speakers (it is not essential to have access to a microphone).
This event will last approximately 2 hours and will feature presentations and an opportunity to submit questions which we will follow up with.