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

Experimental

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