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Abstract Submissions

We're recruiting for papers from experts at the forefront of the extractables and leachables research to present at Extractables and Leachables Europe 2020

DEADLINE: FRIDAY 10 JULY

If you would like to speak on any of the below topics or another topic related to E&L, we'd like to hear from you:

  • Regulatory landscape and requirements for E&L studies
  • E&L case studies
  • Technical advances and novel approaches to E&L
  • Variability and uncertainty in the chemical characterization of E&Ls
  • Unknown E&Ls
  • Safety qualification threshold for sensitization and irritation
  • Effect of E&Ls on the efficacy of proteins, biopharmaceuticals, and cell-based therapies
  • Computational approaches to predict the release of E&L from polymeric materials
  • Medical device and drug device combination products
  • Biocompatibility testing of medical devices
  • E&L guidance on medical devices
  • Effect on surfactants on E&Ls profiles
  • Toxicological risk assessment
  • Flushable substances vs. E&L: risk of accumulation in the first vials/syringes
  • Correlation between E&Ls, how worst-case do we have to go?
  • Shelf-life issues - what happens to the materials after shelf life expires in term of E/L?
  • Scaling
  • Modelling approaches
  • Use of Vion LC-MS in extractable analysis, insights and comparison to other systems
  • Use of GC-QToF in extractable analysis, comparison to single quadrupole GC-MS
  • Variability in the E&L results
  • Interaction of E&L with active ingredients and solutions
  • How to handle change control management?
  • Overview what is possible and the limits of E&L testing
  • Single use systems
  • Extractables and leachables from food packaging material
  • Manufacture of pharmaceutical packaging and labelling
  • Development of analytical methods for extraction and leaching

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