2016 Agenda

View the 2016 program agenda below

Day 1: December 6, 2016

Registration and Coffee

  1. Networking and Coffee

An Overview of the E-Cigarette Market

The e-cigarette market has been estimated to grow to a $50 billion market by 2025. Those estimates were completed before the recent FDA Deeming Regulations were released. What impact will regulation have on the market? 

  1. E- Cigarette Market: past, present and future outlook for the e cigarette industry

    Tim Philips, Director, ECigIntelligence

  2. Overview of the Regulatory framework for E-Cigarettes in US, Europe and ROW

    Azim Chowdhury | Partner of Keller and Heckman LLP

  3. Refreshments will be served

  4. A State Level View of E-Cigarette Regulation

    Presenter: Eric Heyer, Counsel of Thompson Hine

  5. TPD in Europe, notes from the front line, its nicer than you think

    Presenter: Damien Bove, Chief Regulatory Officer, Adact Medical

  6. Multi Front Battle – the Federal and State Attacks on Vapor

    Tony Abboud | Executive Director of Vapor Technology Association

  7. Panel Debate: Future regulatory scenarios and market winners and losers

    Panelists include:

    • Tony Abboud, National Legislative Director, Vapor Technology Association
    • Ian Fearon, Principal Scientist and Head of Clinical Research, British American Tobacco
    • Tim Philips, Director, ECigIntelligence
  8. Lunch

Regulatory responsibility in the E-Cigarette Value Chain

  1. What does it take to get FDA approval for an E-Liquid

    Presenter: Patricia Kovacevic, General Counsel and Chief Compliance Officer, Nicopure

    • Current regulatory requirements
    • What that means for an e liquid manufacturer  
    • What we need from our supply base
    • What we need from the analytical, CRO and toxicology community
    • Our regulatory wish list
  2. Small and medium-size company needs from service providers re the regulatory process for electronic nicotine delivery systems

    David Graham | Chief Impact Officer of NJOY

  3. Afternoon refreshments

  4. Regulatory perspectives for flavours

    Presenter: Janet Aho, VP, Regulatory Affairs & Product Safety, Mane

  5. Regulations for E Cigarettes: Insights from a retailer and manufacturer

    Presenter: Schell Hammel, President, The Vapor Bar

    • Background and history
    • Trends in the industry from a retailers vantage point
    • FDA implications and regulatory issues to address
  6. Closing remarks from chair

  7. Drinks reception

Day 2: December 7, 2016

Registration and Coffee

  1. Networking and Coffee

Test Methods and Risk Assessments

With many steps in the process of registering e-cigarettes, companies have begun to look to independent testing labs to provide much support and insight. Hear from two of the leading independent labs on their testing protocols and processes in both the EU and the USA. 

  1. Updates on Testing Processes for E-Cigarettes

    Presenter: Andrew Feilden of Smithers Rapra

  2. Analysis of E-Liquids and Hardware for TPD2

    Presenter: Scott Fletcher, Director of Analytical Services, Hall Analytical Laboratories

  3. Risk Assessment for E-Cigarettes

    Presenter: Allen Kesselring of EKG Life Sciences

  4. Refreshments will be served

  5. The role of the toxicologist in e-cigarette health risk assessment

    Presenter: Peter Watts, Director of Toxicology, Bibra

    • TPD2 e-cigarette ingredient notifications – toxicology expectations
    • 2Key toxicology considerations for vapers
    • Toxicity data sources overview
    • Health risk assessment process for e-liquids and emissions
  6. Targeted and Non-Targeted Analytical Technologies for Analysis of E-cigarette Products

    Presenter: Naren Meruva, Principal Scientist, Waters Corp

  7. Analytical challenges and solutions for testing e-cigarettes . How to deal with special gas based extraction methods for product evaluation.

    Gyorgy Vas, Ph.D. | Business Technical Scientific Liaison of Intertek

  8. The development of in silico toxicology protocols to support hazard and risk assessment

    Glenn Myatt | Chief Scientific Officer of Leadscope

    • In silico toxicology provides a rapid, low cost and transparent methodology for predicting toxicity
    • There are a number of use cases where in silico approaches have an important role, including evaluation of ingredients, impurities, degradants, extractables and leachables
    • Today, there is a lack of generally acceptable protocols for such an in silico analysis based on the state-of-the-art
    • Such protocols would remove uncertainty in the use of the technology and ensure the results are performed, recorded and archived in a uniform, consistent, defendable and reproducible manner
    • The presentation will describe the development of a series of in silico toxicology protocols through a consortium that includes regulatory agencies and commercial organizations producing different types of products
    • The ICH M7 pharmaceutical impurities guideline uses two in silico toxicology methodologies for the prediction of mutagenicity and will be used as a case study to illustrate such protocol development
  9. Lunch will be served

The Future Regulatory Outlook for E Cigarettes

  1. Choosing a Medicinal Route for E Cigarettes

    Presenter: Robert Burton, Head of Compliance and Consultancy, Nerudia

    Bringing an E-Cigarette to market as an approved medical product

    •             Introduction and experience in medical approval

    •             Regulatory strategy

    •             Filing strategy and process flow

    •             Clinical evaluation

    •             Benefits of this route

    •             Testing methods and scientific opportunities/gaps

    •             Cost vs rewards

  2. Accelerating the regulatory approval process to enable rapid innovation without compromising safety

    Presenter: Ian Fearon, Principal Scientist & Head of Clinical Research, 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 ‘bio similar’s’ approach for E Cigarettes
    • Ensuring there is no safety compromise
  3. The Public Health Case for Diminishing Regulations on E-Cigarettes

    Presenter: Professor Michael Siegel, Professor, Community Health Sciences, Boston University

  4. Closing remarks and close of conference