The Ever-Changing World of ENDS – Free Virtual Conference

Join a variety of ENDS industry experts as they discuss pertinent topics around testing and regulatory approval, and how they impact product development.

The conference will focus 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.


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Speakers & Schedule


8:00am PT/3:00pm GMT/4:00pm BST

David Lawson, CEO, Inter Scientific

PMTA and beyond; a global outlook on ENDS regulatory requirements

8:35am PT/3:35pm GMT/4:35 BST

Chris Wright, Head of Analytical Science, British American Tobacco

Development of analytical testing of e-cigarettes

9:10am PT/ 4:10pm GMT/ 5:10 BST

Robin Lea, Senior Lab Technician & Sydney Singleton, Laboratory Technician, Hall Analytical

The life of an ENDS sample

9:40am PT/4:40pm GMT/ 5:40 BST

Break

9:50am PT/4:50pm GMT/ 5:50 BST

Irene Abraham, SRA RRP Toxicology Director, JT International SA

Toxicological Considerations when assessing ENDS products

10:25am PT/ 5:25pm GMT/ 6:25 BST

Vivienne Tedesco-Ciavarra, Regulatory Services Manager & Evan Richardson, Director of Regulatory Services; Synchrogenix, a Certara Company

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


David Lawson – CEO, Inter Scientific

Title: PMTA and beyond; a global outlook on ENDS regulatory requirements

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.


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

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

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

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

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.


Christopher Wright – Head of Analytical Science, BAT

Title: Development of analytical testing of e-cigarettes

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. 


Irene Abraham, SRA RRP Toxicology Director, JT International SA

Title: Toxicological Considerations when assessing ENDS products

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.


Robin Lea, Senior Lab Technician, Hall Analytical

Title: The Life of an ENDS Sample

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

Title: The Life of an ENDS Sample

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.


Moderator


Pete Gibbons, Head of Tobacco Cessation Product Analysis, Hall Analytical

Pete obtained his PhD in organic chemistry from the University of Liverpool in 2004. He then embarked on an 11 year post-doctoral research career as a drug discovery expert. In 2015 he joined a major independent UK manufacturer of ENDS products as technical manager, responsible for product quality standards and regulatory compliance. Pete joined Hall Analytical in 2021 as head of tobacco cessation product analysis. He is a contributing expert to CEN/TC 437 and ISO/TC 126 WG3.