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The Ever-Changing World of ENDS – On-Demand Virtual Conference

The Ever-Changing World of ENDS – On-Demand Virtual Conference

On 20th May, we gathered variety of ENDS industry experts to discuss pertinent topics around testing and regulatory approval, and how they impact product development. We are delighted to now offer these popular and pertinent presentations on-demand — absolutely free.

The conference focused on:

  • Solving current and future analytical testing requirements
  • Global regulatory requirements 
  • PMTA submissions and strategies 
  • Discussion on potential future regulatory requirements for UK/EU markets

This is a free, educational event that is directly relevant to current and future analytical testing requirements for regulatory approval in numerous markets around the world.

Presentations included:

  • PMTA and beyond; a global outlook on ENDS regulatory requirements – David Lawson, CEO, Inter Scientific
  • How to Get Your PMTA Right the First Time (and what to do if you didn’t) – Vivienne Tedesco-Viavarra, Regulatory Services Manager & Evan Richardson, Director of Regulatory Services at Synchrogenix, a Certara Company
  • Development of analytical testing of e-cigarettes – Chris Wright, Head of Analytical Science, British American Tobacco
  • Toxicological Concerns When Assessing ENDS Products – Irene Abraham, SRA RRP Toxicology Director, JT International SA
  • The Life of an ENDS Sample – Robin Lea, Senior Lab Technician & Sydney Singleton, Lab Technician, Hall Analytical

PMTA and beyond; a global outlook on ENDS regulatory requirements

David Lawson – CEO, Inter Scientific

David specialises in regulatory strategy with a focus on reduced-risk products and tobacco harm reduction. A biochemist by background, having worked in the pharmaceutical industry over 11 years, he was responsible for the development, submission and approval of the first medically approved electronic nicotine delivery system (e-VOKE) and has been closely involved with the regulatory process ever since.

How to Get Your PMTA Right the First Time (and what to do if you didn’t)

Vivienne Tedesco-Ciavarra – Regulatory Services Manager, Synchrogenix, a Certara company

Vivienne Tedesco-Ciavarra is a Fulbright Scholar with a career spanning the pharmaceutical and regulatory writing industries. Vivienne and her team of writer provide regulatory writing services, and she has worked extensively as the nonclinical lead for regulatory submissions of regulated nicotine products in premarket tobacco applications and supports pharmaceutical submissions.

Evan Richardson – Director, Regulatory Services, Synchrogenix, a Certara company

Evan Richardson is an accomplished regulatory affairs professional specializing in eCTD submissions and FDA interactions. With over 15 years of experience, he has a proven record of successful regulatory submissions. As head of Synchrogenix’s Regulatory Services department, Mr. Richardson ensures timely delivery of services, mitigation of risks, and client satisfaction.

Development of analytical testing of e-cigarettes

Christopher Wright – Head of Analytical Science, BAT

Chris joined British American Tobacco in 2008 following a storied career in academia and industry. He became Head of Analytical Science in 2012 and established leading-edge approaches for the analysis of cigarette smoke, nicotine delivery products and other active substances. Chris is a Fellow of the Royal Society of Chemistry and a Chartered Chemist. He has authored and co-authored numerous manuscripts in the areas of dioxins in food, analysis of chemical contaminants and untargeted approaches for the analysis of complex chemical mixtures in aerosols. 

Toxicological Considerations when assessing ENDS products

Irene Abraham, SRA RRP Toxicology Director, JT International SA

Irene has over 10 years of experience as a regulatory toxicologist covering a broad range of substances, products and requirements. She is responsible for the team conducting toxicological risk and product stewardship assessments of reduced risk products, including heat-not-burn. Irene has a doctorate in Toxicology from the University of North Carolina at Chapel Hill, is a diplomate of the American Board of Toxicology and a European Registered Toxicologist.

The Life of an ENDS Sample

Robin Lea, Senior Lab Technician, Hall Analytical

Starting in the ENDS team at Hall Analytical in August 2019, Robin now works as a Senior Lab Technician in the same company. Previously he studied an MChem at the University of Manchester and worked in the materials characterisation lab at Isis, RAL.

Sydney Singleton, Lab Technician, Hall Analytical

Sydney is an MChem graduate from the University of Leeds and has also studied at Eötvös Loránd University in Budapest. She is the most practically experienced technician in aerosol collection for ENDS at Hall Analytical, working on many TPD and PMTA submissions, as well as developing a methodology for HTP aerosol collection.