Medical Device and Medicinal Products Extractables and Leachables Webinar

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.

'As always, Smithers delivered an organised, professional workshop with interesting and relevant presentations' - Analytical Expert - Novartis

Webinar Agenda

Session 1: Extractables and Leachables

  • Origins of E&L
  • Terminology
  • Q&A

Session 2: Regulatory – ISO 10993-18, FDA

  • Regulatory structure and organisations
  • Dose and risk
  • Thresholds
  • Medical devices - regulatory definitions
  • Device categories and risk
  • Combination products
  • Q&A


Session 3: Toxicology

  • The application of toxicological risk assessment in an overall safety evaluation
  • Literature searching and hazard characterisation
  • Dealing with data-deficient compounds and unknowns
  • Derivation of safety benchmarks following appropriate region- and sector-specific guidance, and toxicological risk assessment (TRA)

Interpreting the TRA and determining next steps 

Session 4: Chemical Characterisation, Extractables, leachables

  • Best practices
  • Study design - hypothetical chemical release, exhaustive extraction, leachables etc.
  • Thresholds

Session 5: Experimental

  • Techniques: GC-MS/LC-MS/ ICP/SH GC-MS etc.
  • Interpretation of results
  • Method development/validation
  • Dealing with unknowns
  • Q&A

Webinar Leaders


Guest Speaker


'The presenters were well versed with the E&L standards while providing key information to assist with your projects. A great collaboration of experts and information for those who are either a novice or experienced' - Associate Director - Global Regulatory Affairs, Bausch Health