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Online Workshop: Extractables & Leachables for Medicinal Products

Date: Thursday 22 September 2022

Time: 13:00-17:00 BST

Location: Online

Price: Tickets: €349 + VAT


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


Workshop Agenda

13:00 Introduction to Extractables and Leachables

  • Origins of E&L
  • Terminology

14:00 Regulatory - FDA; EMEA etc

  • Regulatory structure
  • PQRI, USP
  • Dose and risk
  • Thresholds

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

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

16:00 Experimental

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

Workshop Leaders

EL-EU-2021-P-Cummings-Workshop-Card
EL-EU-2021-K-Scott-Workshop-Card
EL-EU-2021-C-Bellis-Workshop-Card-NEW

"Very informative introduction to E&Ls, I took a lot from the workshop and there is a lot I am looking forward to going back over"
- Senior Analytical Scientist, Viatris/Mylan