Date: Thursday 27 June 2024
Time: 13:00-17:00 BST
Format: Online Webinar
Price: €449+ VAT
Join us in June 2024 for an in-depth exploration of Extractables and Leachables (E&L) in medical devices and medicinal products.
This webinar will cover the origins of E&L, terminology, regulatory frameworks including ISO 10993-18, USP and other guidance, toxicological risk assessment, chemical characterization best practices, experimental techniques, and more. Gain valuable insights into interpreting toxicological risk assessments, understanding thresholds, and optimizing study design for extractables and leachables analysis.
We are pleased to announce that bibra have confirmed that they will contribute their knowledge to the webinar, as one of their Senior Toxicologists, Charles Johnson, will be making a presentation
Don't miss this opportunity to enhance your knowledge and stay ahead in the evolving landscape of medical device safety evaluation.
Session 1: Extractables and Leachables
Session 2: Regulatory – ISO 10993-18, FDA
Break
Session 3: Toxicology
Interpreting the TRA and determining next steps
Session 4: Chemical Characterisation, Extractables, leachables
Session 5: Experimental