Chris Waine, bibra toxicology advice and consulting - Qepler Summits And Conferences

Chris Waine


Chris Waine is a toxicologist with 10 years of experience in human health hazard and risk assessment of chemicals. Along with his work on extractables and leachables, he specialises in the evaluation of pharmaceutical impurities, submissions under the EU REACH Regulation and the application of (Q)SAR models for toxicology.

He is a member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.

Related Sessions:

3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 11 Oct 2023
  • Virtual,
  • Pharma
WORKSHOP's Day: Friday, 13 October 2023
CASE STUDY: Health risk assessment of Extractables and Leachables – things are not always what they seem
  • Extractables and leachables (chemical characterisation) studies are a requirement for both medicines and medical devices.
  • E&Ls can arise from containers and closure systems used for pharmaceuticals, from medical devices, and from packaging of both.
  • Uncertainties exist in the characterisation of the source, identity and quantity of E&Ls, which can impact the toxicological risk assessment.
  • This presentation will include several case studies of the toxicity assessment of E&Ls where these uncertainties were addressed.
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