Event Agenda

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

Tuesday 7 November

Pre-Conference Workshop

  1. Workshop: Leachable Risk Assessment: A structured approach to meet regulatory expectations

    Led by representatives from Smithers Rapra and GlaxoSmithKline

    The workshop will focus on leachable risk assessment and therefore a pre-read package on the basics of extractable and leachable with send to delegates in advance of this course, enabling the workshop to devote more time on the technical risk assessment process. The workshop is designed to give practical experience of performing a technical risk assessment to evaluate exposure risk to patients from leachables derived from container closure or manufacturing materials and then use extractable and/or leachable testing as risk reduction activities to meet regulatory expectations.

    It will consist of a mixture of short  presentations and predominately an interactive element performing a risk assessment on a fictitious medical product.  The facilitators from Smithers Rapra, Baxter Healthcare and GSK will assist in the workshop and give the presentations.

    The presentations will cover the concepts and themes associated with a science led risk based approach to extractable and leachable testing and its close alignment to concepts of quality by design and lifecycle management aligned to guidance of Drug Product Development (ICHQ8) and Quality Risk Management (ICHQ9).

    Interactive element will cover:

    Risk identification (cause and effect)
    Risk evaluation & analysis (knowledge gathering and scoring)
    Risk reduction (Extractable and/or leachable testing)

    The workshop will cover the entire day and will include a light lunch. Please ensure you include your role in extractables and leachables when booking your ticket so teams can be assigned with a diverse mixture of people.

    Please note the workshop will run from 9.30am-5.30pm.

Wednesday 8 November

Wednesday 8 November

  1. Event Registration and Pre-Conference Networking

  2. Opening Remarks and Introduction from the Chair

Regulatory landscape, expectations and protocol insights

  1. Regulatory changes and setting standards for extractables and leachables – how is it done?

    Melanie Pires, Senior Pharmaceutical Assessor, MHRA

  2. FDA’s expectations for equipment compatibility studies for manufacturing of liquid dosage forms

    Edwin Jao, Branch Chief, FDA

    • Why are equipment compatibility studies needed?
    • What compatibility data should be provided?
    • Similarities and differences between equipment and container/closure system in terms of compatability
    • Compendial chapters and guidances for container/closure system the principles and approaches of which can be referenced. Draft compendial chapters for compatibility of manufacturing equipment
    • Proposal for risk-based approach
    • Case studies for consideration
  3. Insights and lessons learned from implementation of USP and BPOG extractable protocols

    Gilbert Tumambac, Senior Principal Scientist – Regulatory and Validation Consulting Group, Pall Life Sciences

    • Extractables from single-use components
    • Implementation of BPOG protocol
    • BPOG vs USP solvents comparison
  4. Networking Refreshment Break

  5. Panel discussion: BPOG vs. USP: What is expected to be used and what is the current trend to work towards?

    Panellists to be announced! 

Case studies

  1. The challenges of developing permitted daily exposure (PDE) values for extractables

    Greg Erexson | Senior Principal Research Scientist of AbbVie

    • Risk assessment
    • Permitted daily exposure (PDE) values
    • ICH Q3C(R6)
    • ELSIE
  2. Networking Lunch

  3. The journey of revealing unknowns and impurities by material knowledge (The origin of species)

    Lise Vanderkelen | Department Head Pharma Services of Toxikon Europe

    • Material characterisation
    • Controlling the unknowns
    • Identifying impurities
    • Case studies
  4. Leachable Risk Management for Commercial Products: Hypothetical Scenarios that Emphasise When Experimental Work is/isn’t Required

    Mike Hodgson | Global Extractables & Leachables Senior Manager of Baxter International Inc

  5. Automation possibilities using the Gerstel Multipurpose sampler for extractable and leachable studies

    Dan Carrier, Applications Laboratory Manager, Anatune and Ivan Kourtchev, Investigator, GSK

    • Automated DLLME (Dispersive Liquid Liquid Micro Extraction)
    • Single drop micro extraction (SDME)
    • Gerstel multipurpose sampler
    • Automated centrifugation
    • Gas chromotography
  6. Networking Refreshment Break

Learnings from food contact materials relevant for the pharma industry

  1. Migrant health risk assessment and supporting toxicity data sources

    Pete Watts | Director of Toxicology of bibra toxicology advice and consulting

    • Migrating food-contact substances are ingested with foods/beverages
    • These exposures to “indirect food additives” require health risk assessment
    • Principles of health risk assessment will be described
    • Robust assessment requires comprehensives toxicity/hazard assessment
    • Toxicity data sources will be described
  2. What can we learn from food?

    Smithers RAPRA

    • Regulations
    • Toxicology
    • Similarities and differences

Networking Drinks Reception

  1. Networking Drinks Reception

Thursday 9 November

Thursday 9 November

  1. Registration and Welcome Refreshments

Medical Devices

  1. Colour and safeguard your liquid silicone rubber for medical applications with biologically tested and change controlled special solutions

    Beate Treffler | Regional Head Europe, Segment Healthcare Polymer Solutions of Clariant

    • Colour and safeguarding your liquid silicone rubber for medical applications
    • Safety and reliability of the medica device over the device’s whole life cycle
    • Encounter and manage risks which come along the supply chain
    • More complex regulations for medical devices e.g. re-write of the USP <87><88> biocompatibility evaluations request more controls at tier 2 suppliers
    • Sound solutions for LSR with technical aspects and regulatory benefits of medical liquid colour
  2. Leachable risk assessment (chemical characterization) of medical devices

    Tiru Kumaravel | Chairman of GLR Laboratories

  3. Examination of Extraction Process Variables on Medical Device Component Extractables

    Alan Hendricker | Manager - Chemical Sciences of Becton Dickinson

    • Medical devices
    • Mass Spectrometry
    • ISO-10993
    • Materials selection best practices
  4. Networking Refreshment Break

Biocompatability

  1. Extractable/leachable chemistry for medical device biocompatability assessment

    Matthew Jorgensen, Chemistry and Materials Scientist, Nelson Laboratories

    • Extractable/leachable chemistry and assessment of medical device biocompatibility
    • Strategies for handling semi-quantitive compounds
    • Assessment of results for regulatory approval
  2. Leachable silicone oil in biopharmaceutical formulations

    Xiaochun Yu | Principal Scientist of PPD

    • Leachables silicone oil
    • Biopharmaceutical formulations
    • ICP/OES
  3. ISO 10993 Extraction Conditions and ISO Interlaboratory Study Examining Them

    Anita Sawyer | Biocompatability and Standards Manager of Becton Dickinson

  4. Panel discussion: Device testing: What can be learned from drug product E&L testing and visa versa

    Panellists to be announced!

  5. Networking Lunch

Current challenges in the E&L arena

  1. Bridging extractables and leachables – mass transport modeling for rationalized study designs

    Thomas Egert | Analytical Development of Boehringer Ingelheim Pharmaceuticals

  2. E&L challenges for electronic nicotine delivery systems (ENDS)

    Malcolm Kimber | Laboratory Operations Director of Hall Analytical Laboratories

  3. Chair Closing Remarks