We're recruiting for papers from experts at the forefront of the extractables and leachables research to present at E&L Europe 2019 in London.
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?
- 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
Deadline: Friday 26 April 2019
Please ensure you select 'Extractables and Leachables Europe 2019' using the drop down box at the beginning of the form submission to ensure your abstract is submitted for the correc event.