Webinar: Extractables & Leachables for Medicinal Products

Date: Thursday 22 June 2023

Time: 13:00-17:00 BST

Location: Online

Price: €429 + VAT

Topics: Intro to E&L; terminology, regulatory structure; PQRI & USP; best practices & study design; techniques; dealing with unknowns, and more.

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

Webinar Agenda

13:00 Introduction to Extractables and Leachables

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

14:00 Regulatory - FDA; EMEA etc

  • Regulatory structure and organisations
  • Dose and risk
  • Thresholds
  • Q&A

14:45 Break

15:00 Toxicology 

  • 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

  • A bit about medical devices 
  • Extractables assessments
  • Leachables and simulations
  • Toxicological evaluation - where does this fit in?


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

Webinar Leaders


'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