Webinar: Extractables & Leachables for Medical Devices

Date: Wednesday 21 June 2023

Time: 13:00-17:00 BST

Location: Online

Price: €429 + VAT

Topics: Intro to E&L; ISO 10993, ISO 18562, FDA and EMA; best practices & study design; techniques; method development, and more.

"Very insightful and perfectly tailored to meet industry requirements"
- Senior Quality Engineer, Mallinckrodt Pharmaceuticals

Webinar Agenda

13:00 Introduction to Extractables and Leachables

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

13:45 Regulatory - ISO 10993-18, FDA

  • Regulatory structure and organisations
  • Medical devices - regulatory definitions
  • Device categories and risk
  • Combination products

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

  • The application of toxicological risk assessment in an overall safety evaluation
  • Literature searching and hazard characterisation                                                                   -  Identification of existing toxicological data through comprehensive literature searching                                                                                                                                      - Selection of the Point of Departure for the critical health hazard(s)
  • Dealing with data-deficient compounds and unknowns                                                          - Filling data gaps using (Q)SAR and/or read-across                                                               - - Application of the Threshold of Toxicological Concern (TTC) to data poor and unknown E&Ls
  • Derivation of safety benchmarks following appropriate region- and sector-specific guidance, and toxicological risk assessment (TRA)
  • Interpreting the TRA and determining next steps

16:00 Chemical characterisation, Extractables, Leachables

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


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

Webinar Leaders


"A wonderful and beginner-friendly experience, perfect for those just starting out in the industry"
- Toxicologist, bibra toxicology advice & consulting