Event Agenda

Below is the 2017 Agenda outlining topics discussed at the 11th Annual Extractables & Leachables conference in Lyon.

Wednesday 8 November 2017

Thursday 9 November 2017

Session 1: Regulatory Landscape, Expectations and Protocol Insights

Session 4: Medical Devices

  • Regulatory changes and setting standards for extractables and leachables - how is it done? MHRA
  • Insights and lessons learned from implementation of USP and BPOG extractable protocols, Pall Life Sciences
  • Extractables & leachables - where does the risk really lie? Eli Lilly
  • The challenges of developing permitted daily exposure (PDE) values for extractables, AbbVie
  • Panel discussion: BPOG vs USP - what is expected to be used and what is the current trend to work towards? Novo Nordisk, Pall Life Sciences, Triad Scientific Solutions, Eli Lilly
  • Colour and safeguard your liquid silicone rubber for medical applications with biologically tested and change controlled special solutions, Clariant
  • Leachable risk assessment (chemical characterisation) of medical devices, GLR Laboratories
  • Examination of extraction process variables on medical device component extractables, Becton Dickinson 

Session 2: Case Studies

Session 5: Biocompatibility

  • Automation possibilities using the Gerstel Multipurpose sampler for extractable and leachable studies, Anatune and GSK
  • The journey of revealing unknowns and impurities by material knowledge (The origin of species), Toxikon
  • Leachable risk management for commercial products: hypothetical scenerios that emphasise when experimental work is/isn't required, Baxter
  • Agilent solutions from extractables profiling to leachables testing, Agilent Technologies
  • Extractable/leachable chemistry for medical device biocompatibility assessment, Nelson Laboratories
  • Leachable silicone oil in biopharmaceutical formulations, PPD
  • ISO 10993 extraction conditions and ISO interlaboratory study examining them, Becton Dickinson
  • Implementation of BPOG best practices guide for leachables: Leachables study design, Bristol-Myers Squibb
  • Panel discussion: Device testing - what can be learned from drug product E&L testing and vice versa, AMRI, Becton Dickinson, Toxikon, Knoell, Novo Nordisk, Triad Scientific Solutions

Session 3: Learnings from Food Contact Materials Relevant for the Pharma Industry

Session 6: Current Challenges in the
E&L Arena

  • Migrant health risk assessment and supporting
    toxicity data sources, bibra
  • What can we learn from food? Smithers Rapra
  • Bridging extractables and leachables - mass transport modeling for rationalised study designs, Boehringer Ingelheim
  • E&L challenges for electronic nicotine delivery systems (ENDS), Hall Analytical