2018 Agenda

Tuesday 6 November

Registration and welcome refreshment

  1. Registration and welcome refreshment

Pre-Conference workshop

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

    Dr. Andrew Feilden | Chemistry Operations Director of Smithers Rapra

    Led by representatives from Smithers Rapra

    Tuesday 6th November: 9:30 - 17:30 (registration from 9am and lunch included)

    The workshop will focus on leachable risk assessment and 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 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 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.

    Tickets are just £799 in addition to your 2-day conference ticket. Places are limited so we advise booking as soon as possible to avoid missing out!

    Please note, you must book (or have already booked) an Extractables & Leachables Europe 2018 conference ticket in order to attend the workshop.

  2. Workshop ends

Wednesday 7 November

Wednesday 7 November

  1. Registration and welcome refreshment

  2. Chairman’s opening remarks

    Dr. Andrew Feilden | Chemistry Operations Director of Smithers Rapra

Session 1 – Regulatory landscape, standards and impact

  1. European perspective on extractables and leachables

    Melanie Pires | Senior Pharmaceutical Assessor of Medicines and Healthcare products Regulatory Agency (MHRA)

  2. Regulatory acceptance of alternative methods to assess the toxicity of E&Ls

    Ronald Brown | Toxicologist of U.S. FDA (retired)

  3. The USP's approach to extractables and leachables for drug product components and packaging/delivery systems

    Dr. Michael Eakins | Founder and Principal Consultant of Eakins and Associates

    • USP's General Chapters and their accompanying General Information Chapters for glass containers, elastomeric and plastic components and packaging systems are currently undergoing major revisions that include revision of both the test methods for physicochemical properties and revised sections for extracted compounds and elements.
    • The presentation will cover the key issues and areas of the proposed changes to provide an overview of the direction of change and the current progress to date.
    • Key issues in the current revision of the Glass containers chapters <660> and <1660> include the current approach to revising the glass grains and inner surface extraction methods and analytical procedures.
    • Key quality issues will be also addressed  for Elastomeric components and Plastic packaging and manufacturing components.
  4. Networking break

  5. Regulatory uncertainty and its potential impact

    Andrew Teasdale | Senior Principal Scientist Impurity Management and External Advocacy of AstraZeneca

Session 2 – Case studies and analytical challenges

  1. Issues frequently observed in analytical evaluation of leachables in drug products (a review experience)

    Andrey Sarafanov | Chemist, Principal Investigator Center for Biologics Evaluation and Research (CBER) of U.S. Food and Drug Administration (U.S. FDA)

    • Analytical recovery of certain compounds can be underestimated
    • This may result in underestimation of respective risks for patients
    • Possible approaches to avoid that are discussed
  2. The relationship between ICH guidelines for impurities (M7 & Q3) and extractable & leachable thresholds

    Raphael Nudelman | Ph.D., ERT, Dir., Chemical & Computational Toxicology of Teva Pharmaceuticals

  3. Networking lunch

  4. Challenges during the development and execution of E&L strategies for inhaled products

    Graham Wilson | Senior Manager Extractables & Leachables of Mylan

  5. pMDI leachable study using GC-MS and thermal desorption

    Rick Reiley | Senior Scientist of GlaxoSmithKline

  6. Application of a data deconvolution software package for analysis of non-volatile extractables and leachables in polymeric matrices

    Ivan Kourtchev, Scientist, GlaxoSmithKline and Ewan Pickard, Principal Scientist, Smithers Rapra Ltd.

  7. Networking refreshments break

  8. Continuous improvement on extractables and leachables assessment of plastic materials used for production, packaging, and administration of biopharmaceuticals: from a user perspective

    Alicja Sobantka | Corporate Operational Excellence and Support of Octapharma

  9. Extractables and leachables assessment for cryostore cell and gene therapy containers

    Raymond Colton | Founder and President of VR Analytical

  10. Panel discussion

    Panellists: Ronald Brown, U.S. FDA; Melanie Pires, MHRA; Andrew Teasdale, AstraZeneca; Rick Reiley, GSK; Raphael Nudelman, Teva Pharmaceuticals

    • How the regulatory landscape is changing and what it means for industry? What can we expect in the future?
    • What should be included/excluded in the BPOG protocol?
    • ISO combined with USP - is there an alignment ?

    Panel Moderator: Dr. Andrew Feilden, Chemistry Operations Director, Smithers Rapra Ltd.



  11. Chair’s conference summary and closing remarks

    Dr. Andrew Feilden | Chemistry Operations Director of Smithers Rapra

  12. Networking drink reception

    Networking drink reception from 18.10 to 19.40

Thursday 8 November

Thursday 8 November

  1. Registration & welcome refreshments

  2. Chairman’s opening remarks

    Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk

    Carsten Worsøe

Session 3 – Medical device and drug device combination products

  1. Biocompatibility testing of medical devices

    Clemens Günther | Director Nonclinical Safety Consumer Care of Bayer AG

    • Understanding the nonclinical safety evaluation of medical devices
    • Clarifying the requirements for biocompatibility testing according to ISO-10993
    • Selecting an appropriate test strategy and avoiding potential pitfalls
  2. Toxicological risk assessment of medical device constituents: proposed changes to ISO 10993-17

    Dr. Sherry Parker | Toxicology Director of WuXi AppTec, USA

    The Working Group for ISO 10993-17 is preparing a new draft of the standard. This presentation will include the following:

    • New Clauses (including Hazard Identification, Exposure Assessment, Dose-Response Assessment, and Risk Characterization)
    • The use of TTC and read-across
    • The role of expert judgement in risk characterization and risk mitigation
    • Toxicological equivalence of medical devices
  3. Important aspects and approaches in carrying out a toxicological risk assessment on extractables and leachables for medical devices

    Dr. Albrecht Poth | Senior Toxicologist of Dr. Knoell Consult GmbH

  4. Networking refreshments break including poster sessions

    Attend the Poster Session in the exhibition hall to find out about cutting-edge E&L science and put your questions to the authors. See the confirmed posters here: https://www.eandl-conference.com/europe/poster-sessions

  5. What does FDA want to see in a risk assessment of E&Ls from medical devices?

    Ronald Brown | Toxicologist of U.S. FDA (retired)

  6. Case study-advantages and disadvantages for using E&L studies during the development process of medical devices

    Dr. Alexander Koerner | Project Manager - Biocompatibility of Roche Diabetes Care GmbH

  7. Panel discussion

    Panellists: Alexander Körner, Roche; Albert Poth, Knoell; Sherry Parker, Frensenius Medical Care; Ronald Brown, former FDA

    • The future of biocompatibility testing
    • ISO 10993 part 18 revision process
    • What can be learned from drug product E&L testing and vice versa? 
    • What is (still) needed to avoid animal testing and only rely on E&L-Testing?
    • Variation in chemical characterisation lab results for device biocompatibility

    Panelmoderator: Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk


  8. Networking lunch

Session 4 - A suppliers perspective

  1. Polymer variance – a critical consideration for E&L studies

    Dr. James Stern | Head of Business Development, Healthcare of ALBIS Kft

    • Polymers are not identical, even with the same specifications
    • E&L testing without consideration of basic polymer variation does not make sense
    • Change control manages variation increasing relevance of subsequent testing
  2. Differentiating SABIC’s engineering resins with extractables & leachables data

    Hans de Brouwer | Chief Scientist, Healthcare of SABIC

  3. The proper use of extractables data – aspects beyond extractables measurement

    Dr. Armin Hauk | Lead Scientist R&D of Sartorius-Stedim Biotech GmbH

    • Protocols for conducting extractables studies for SUS are available today, but two questions persist and cannot be solved by means of analytics alone:
    • How can extractables data be obtained for devices of different sizes and for device combinations, taking the vast number of devices and combination of devices into account?
    • How can extractables data be extrapolated towards potential leachables under process conditions?
    • A methodology based on physical principles will be introduced which is able to solve these problems. The capability of the methodology will be illustrated with case studies.
  4. Debunking the Leachable Myths of Gamma Sterilization: A Migration Study of Steam Vs. Gamma

    Francois Billard | Director of Operations of Next Breath, an Aptar Pharma Business

    • Review sterilization practices
    • Regulatory impact of leachables
    • Migration study comparing coated and uncoated elastomer

    Steam 1x, 2x and 3x

    Gamma 25, 32 and 50 kGy

  5. Chair’s conference summary and closing remarks

    Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk

    Carsten Worsøe
  6. End of conference