2017 Agenda

See below for the programme for ENDS 2017

Wednesday 14 June

Wednesday 14 June

  1. Registration and Welcome Refreshments

  2. Chair's Opening Remarks

ENDS Regulatory Landscape and Future Forecasts

  1. Overview of ends and vaping

    Charles Hamshaw-Thomas | Head of Corporate and Legal Affairs – Europe and Board Member at UK Vaping Industry Association (UKVIA) of Nicopure Labs

  2. Implementing TPD2 for e-cigarettes and where have we got to

    Beryl Keeley | E-Cigarette Notification Scheme Lead of Medicines and Healthcare products Regulatory Agency (MHRA)

  3. Demystifying CLP classification of e-cigarette products

    Dr. Dilip Bhuva | Chief Science and Compliance Officer of Xyfil

  4. Common mistakes in e-cig research, and how to avoid them

    Tom Pruen | Chief Scientific Officer of Electronic Cigarette Industry Trade Association

  5. Networking Refreshment Break

  6. Developing standards for Electronic Cigarettes for the UK, Europe and beyond

    Nele Zgavc | Programme Manager, Governance & Resilience - Healthcare of British Standards Institute (BSI)

    • A short introduction to standards development
    • How is the UK involved with European and international standardization
    • What standards can we expect in the e-cigarette field
  7. Best practices for extractables and leachables testing of ENDS

    Charles Ducker, Principal Chemist/Group Leader, Eurofins Medical Device Testing

  8. Panel Discussion: ‘Best practice and how to approach?’

    Panellists: 
    Patricia Kovacevic, General Counsel and Chief Compliance Officer, Nicopure Labs
    Tom Pruen, Chief Scientific Officer, Electronic Cigarette Industry Trade Association (ECITA)
    Gregory Brown, General Counsel, Space Jam Juice 
    James Murphy, British American Tabacco (BAT) 

  9. Networking Lunch

Testing Standards, Methods and Potential Harm Reduction

  1. Challenges of eliquid and vapour analysis: The need for standard methods and safe limits for substances of concern

    David Dawit | Chief Scientific Officer of Eos Scientific

    The electronic cigarette industry being new and rapidly evolving, analytical methods required for both quality control and regulatory submission tests are mostly in- house developed. The products were unregulated in Europe until very recently. The EU Directive commonly known as the Tobacco Product Directive (TPD II) was passed in 2014. Article 20 of this regulation requires electronic cigarettes product manufacturers to submit safety assessment test results and this came into force in May 2016 with a 6-month grace period. However, requirements for analytical methods to be used for identifying and quantifying substances of interest with regard to the new regulation were not included. This led to different interpretation of what to test for and what methods to use. The Medicines & Healthcare products Regulatory Agency (MHRA) guidelines and subsequently, the MHRA submission portal itself were useful indicators of the substances of interest to test for but lack of standard methods, validation acceptance criteria including detection limits are still not yet clear.

    A good example signifying the need for standard methods and limits, is the huge controversy regarding diketones (Diacetyl, Acetyl Propionyl). Some producers claimed their products to be diketone free whereas at close investigation the method detection limits were as high as 0.1% (1000 ppm) making the claims inaccurate and perhaps dangerous. Another problem was what parameters to use for emission testing. It also meant with different devices and different settings of wattage, make of material average number of puffs per day for different strengths of nicotine, it was impossible to set parameters that can be used as a standard testing procedure. The additional problem of the sheer number of flavours, variation in Propylene Glycol, Vegetable Glycerin (PG_VG) ratio exacerbated the problem. The available literature is very limited and some were very specific to be used as a point of reference. As regulations in the UK and worldwide continue to evolve, the industry is looking to advanced instrumentation and analytical testing to comply with new quality standards. There are a few standards that are being studied and in some cases used as a reference by different analytical labs, for example the French standards (AFNOR), however, we feel industry-wide consultation and collaboration with guidance from the regulator is the only way forward.

    It is understandable that setting safe limits for substances of concern may not be possible in the near future due to the relatively short period of the existence of electronic cigarette products. There is limited research, and the long term effects of constituents of e-liquid can only be understood clearly with time. Nevertheless, for some substances of concern such as metals, permissible exposure limits of the inhalation pathway set for drugs can be adopted in one way or another after consultation with all stakeholders. This will indirectly help set the methods and acceptance criteria for the analytical process.

  2. The value of collaboration in the development of e-cigarette test methods

    Derek Mariner | CORESTA E-Vapour Subgroup of CORESTA

  3. A proposed bridging approach for the assessment of novel tobacco products

    Dr. Ian M. Fearon | Principal Scientist and Head of Clinical Research of British American Tobacco

    • The current challenge for bringing new e-cigarette products to market
    • The public health advantage of speed to market for new innovation
    • Developing a ‘biosimilars’ approach for e-cigarettes Ensuring there is no safety compromise
  4. Networking Refreshment Break

  5. Science and evidence to demonstrate potential harm reduction: electronic cigarettes

    Willie McKinney | Vice President Regulatory Sciences of Altria Client Services (ALCS)

    • Both public health and FDA acknowledge a continuum of risk among tobacco products
    • Altria is committed to seek market authorization from FDA for innovative lower risk products like electronic cigarettes
    • Will share framework for scientifically demonstrating harm reduction and highlight many of our findings to date
    • Highlights will include data summaries from constituent analysis, stability testing, and ingredient toxicological evaluations
  6. Panel Discussion: ‘Tobacco Harm Reduction and negativity towards e-cigarettes‘

    Panellists: 
    Ian Fearon, Head of Clinical Research, British American Tobacco (BAT)
    Charles Hamshaw-Thomas | Head of Corporate and Legal Affairs – Europe and Board Member at UK Vaping Industry Association (UKVIA) of Nicopure Labs
    Simon Manthorpe, CEO, EosLeisure
    Scott Fletcher, Director of Analytical Services of Hall Analytical

  7. Chair Closing Remarks

Evening Networking Drinks Reception

  1. Evening Networking Drinks Reception

Thursday 15 June

Thursday 15 June

  1. Registration and Welcome Refreshments

  2. Chair's Opening Remarks

Product Design, Testing Materials, Labelling and Manufacuring Protocols

  1. Analysis of liquids and hardware; PMT and TPD regulations

    Scott Fletcher | Director of Analytical Services of Hall Analytical

  2. E-liquids and e-cig hardware: toxicology, C&L and ongoing safety assessment obligations

    Richard Young, Principal Toxicologist and Pete Watts, Director of Toxicology, Bibra toxicology advice and consulting

    • Feedback on notifications – adequacy, detail of submissions
    • TPD notification deadline is past, but safety obligations endure
    • Health hazard and risk assessment of notified e-liquids and emissions
    • Classification and Labelling (C&L) of e-liquids
    • New e-liquid formulations
    • New hardware/devices – extractables and leachables
  3. Eliquidity

    Matthew Bland | Business Development Director of Eliquid Solutions

  4. Networking Refreshments Break

  5. In silico toxicology protocols and best practices

    Glenn J. Myatt, Ph.D. | Chief Scientific Officer of Leadscope

  6. Advertising e-cigarettes and related products in line with the CAP Code

    Jo Davis | Copy Advice Executive of Committee of Advertising Practice (CAP)

  7. Networking Lunch

  8. Product design and manufacturing and what’s next?

    David McLaughlin | Director, Business Development of Elucid8

  9. ENDS testing: extending extractables and leachables knowledge from pharmaceutical products

    Dr. Daniel Norwood | Executive Partner of SCIO Analytical & Senior Consultant at Smithers Rapra

  10. Close of Conference