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Agenda

All timings shown are UK BST 

Chair welcome and introduction
Chair's opening remarks
Global flavour development trends
Global Flavour development trends in open system devices taken from ECigIntelligence new Flavour Tracker
  • Flavour policy in Europe, and the development of restrictions on flavoured vape products
  • How flavour policy development will affect other combustible-alternative products such as heated tobacco and nicotine pouch
  • Enforcement of flavour restrictions, and the future of flavours in this category

Tim Phillips | Managing Director, ECigIntelligence
Behavourial studies on flavours
 
  • Research findings on the impact of flavours on ENDS initiation and smoking cessation
  • The impact of flavours on nicotine pharmacokinetics and user behaviour
  • How the FDA is viewing flavours

Ian Fearon | Consultant, whatIF? Consulting Limited
Flavour bans and what needs to change
  • Understanding e-liquid flavouring
  • The risk of flavour-bans
  • What needs to be changed

Rob de Lange | Secretary, ACVODA
Break
The toxicity assessment of flavours
  • The application of pre-clinical toxicological testing as part of a  weight of evidence approach
  • The importance of stewardship safety assessments to maintain quality and standards of all ingredients and flavourings
  • The application of pre-clinical toxicological testing approaches and screening technologies, including direct e-liquid testing and aerosol testing using human lung tissue models, and key experimental considerations to ensure adequate and appropriate testing
  • Pan-industry approaches with various working groups to harmonise testing strategies
  • Summarising some of the key issues with e-liquid (flavour) assessment and propose some best practices  for a robust testing strategy, which will give more scientific insight into the relative risks and the role flavours can play within the e-cigarette category

David Thorne | Senior Scientist, Pre-Clinical Research, British American Tobacco
Product Stewardship of Flavours
Flavours are the most chemically complex component of e-liquids, and also a very important one for smokers to make the transition from cigarettes into vaping. As a responsible industry with a duty of care towards consumers, it is crucial to ensure that e-liquids continue to represent a safer alternative to cigarettes. In this respect it is necessary to have a level of product stewardship of flavours that derives a level of inclusion of each ingredient within e-liquids that will not deliver undue levels of chemicals to the consumer, and that ensures e-liquids always offer a safer alternative to smoking. This presentation will consider the ways in which a toxicological risk assessment of flavours can be used to derive such permissible concentrations of flavour ingredients in e-liquids, through combinations of in-vitro testing, in-silico predictions and desk-based review of available toxicological studies as part of a weight of evidence approach.
 
Dr Juan Lopez-Belmonte | Head of Group Product Stewardship , Cuts Ice Ltd
All speaker Q&A session
Summary and close of event
Welcome from Smithers
Welcome
Market spotlight – regulatory considerations and analysis of key markets
Competent or careless? Directions in European policy on low-risk nicotine products
  • Signals and statements of intent about European Union policy
  • The problem of unintended consequences
  • A better way - risk proportionate regulation
  • How to engage

Clive Bates | Director, Counterfactual Consulting Ltd
Europe - market spotlight – key challenges, regulations, market potential
US Market Focus and How the ENDS Regulatory Framework and the EVALI Crisis in the US Have Echoed Around the World
Key considerations when developing new products and how trends in global regulations could impact such decisions
Tao Cui, Director, Innokin  
Networking Break
PMTA requirements, standards updates and compliance
The compliance of ENDS regulations with international law
Dr. Marina Foltea, Founder and Managing Director, Trade Pacts
A Pre-Market Assessment of Intention to Use the RELX Infinity ENDS Among National Probability Samples of Legal Age Adults in the United States
 
•             RELX Infinity ENDS
•             RELX PRO e-liquid pods
•             Adults’ perceptions and use intentions
•             Pre-market quantitative assessment
•             Potential population health impact
 
Christopher Russell | Director, Russell Burnett Research and Consultancy Limited
Flavours - Standards update
  • The breadth of flavours available in e-liquids is often cited as a reason that some may be unsafe
  • Technical standards can ensure minimum safety levels for flavours agreed by the various stakeholders, incl. regulators, industry and consumers
  • A CEN standard is currently being drafted, setting requirements for e-liquid ingredient safety
  • Main requirements in the current draft will be presented
  • Considerations to ensure the standard will be practical and enforceable will be discussed

Sandra Costigan | Principal Toxicologist, British American Tobacco
Scientific cooperation for international standard developments relative to e-vapor products
Welcome
Understanding the consumer and industry expectations
RELX Guardian Programme: Commitment to Youth Prevention
CARE – Comparative Assessment of Real-world ENDS use
 
  • Within the context of the TPD it is important to understand how variety in ENDS design may meet the needs of diverse smoker groups
  • This study will look at the appeal and impact of diverse ENDS on individual smokers.
  • Assessing the rate at which individual smokers using ENDS are able to quit or reduce their smoking
  • Study output will characterize the relative impact and appeal of diverse ENDS.
  • Along with the importance of variation in ENDS design 
  • Reports will be made available to manufacturers and public health and regulatory bodies

Gabriel Barnard | Head of Business Development, CSUR
Flavours and the consumer
Testing, toxicology and analytical updates
Rapid vapour phase measurement of volatile HPHCs using TD-SIFT-MS
  • Overview of TD-GC-MS & TD-SIFT-MS in the ENDS space.
  • Comparison of the techniques.
  • Future benefits of the SIFT-MS.
Dr. Mark Perkins, Senior Application Chemist & SIFT-MS Specialist, Anatune Ltd
Sally McGuigan | Principal Scientist, Hall Analytical Laboratories Limited
Networking Break
Extractables & Leachables – why they’re important to ENDS and e-liquid products
 
  • What are extractables and leachables (E&Ls)?
  • Why do regulators regard them as important when considering whether to grant a licence for a new ENDS/e-liquid product? 
  • What do E&L studies involve?
  • Why is an E&L risk assessment essential in effectively mitigating the risk E&Ls pose to consumers?
  • How are regulatory requirements on E&Ls likely to evolve around ENDS/e-liquids?
  • E&L case studies from the pharmaceutical industry

Shane Smith | Managing Director, ExtLe Solutions Ltd
Emerging products, regulation and new innovations
The ENDS Regulatory Battleground of Tomorrow
 
  • ENDS products have revolutionised the ability for smokers to use nicotine in a less harmful way.
  • The focus of reducing the harm to smokers has thus far ignored the harm these products may cause the environment.
  • Regulation is evolving to have a greater focus on the materials used in ENDS products.
  • As an industry our focus should not be only on Tobacco Harm Reduction but on Total Harm reduction - a reduction in harm to smokers and our planet.

Dr. Nveed Chaudhary | Chief Regulatory Officer, Broughton Nicotine Services
Changing consumer behaviour and the role of regulation in new nicotine products
 
  • Presentation of ECigIntelligence consumer data suggesting moves towards smaller vape devices, pods and disposables, and the impact of changing hardware on flavour and nicotine trends; 
  • Continuing fragmentation of heated tobacco products, particularly the growth in substitutable hardware and compatible consumables products including hemp/CBD heat sticks;
  • The growth in tobacco-free nicotine pouches, and the substitution of traditional oral tobacco products such as snus and chew
  •  US: what to expect from the FDA under a new Biden administration in 2021, and the impact of mailing restrictions and PACT for online retailers
  • UK: TPD post-Brexit, and the opportunities for the UK market

Tim Phillips | Managing Director, ECigIntelligence
CBD – human health considerations for use as a novel e-liquid ingredient
 
  • Introduction to cannabidiol (CBD) and current interest in its use (including in electronic delivery devices)
  • Overview of the key laboratory animal toxicity data
  • Overview of the key human data (e.g. clinical trials)
  •  Issues and challenges in assessing safety for inhalation use

Richard Young | Principal Toxicologist and Managing Director, , Bibra toxicology advice & consulting Ltd
The future of oral tobacco and nicotine products
Chair’s closing remarks and end of of event

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