• Understanding the various players participating on the international health policy stage – the role of the World Health Organisation, the FCTC COP, and others.
• How best to use the policy hooks in the FCTC to shape national nicotine policy, drive tobacco harm reduction and establish risk proportionate regulation.
• Alternatives to smoking – protecting the human rights of those who wish to have access to and information about less harmful nicotine options.
• The role of domestic judiciaries in promoting compliance with treaty obligations and protecting treaty-based private rights.
• Comparisons and differences between the Framework Convention on Climate Change and other industries impacted by international regulatory policy.

•  Considerations for new products – understanding the consumer and the competition
• Understanding the product – demonstrating its characteristics and harm reduction potential
• Current and emerging regulations – applicability of MAA and sustainability of PMTA.

• FDA & the Future of Flavors given recent FDA announcements that it will seek to ban menthol cigarettes and flavored cigars, and the likelihood of Congressional action
• PMTA Application Process Update: What does the industry look like post application and what will this mean in terms of product accessibility and choice?
• Emerging Trends in the Nicotine Industry including disposable ENDS and Synthetic Nicotine

• What are Extractables and Leachables?
• Why are the regulators interested in them?
• What does an Extractables and Leachables assessment involve?
• How is the regulatory landscape around Extractables and Leachables likely to evolve with respect to current and future vaping products?

• Latest FDA developments over the past 9 months
• Role of governments in accurately communicating comparative risk of nicotine products
• Government action and its impact on consumer behaviour

• Setting the Foundation: The 3 C’s of cGMPs
• Building Quality into the Manufacturing Process – Impact on PMTAs
• FDA Inspections
• Remote Regulatory Assessments (RRAs): How to prepare and what to expect

• Part (1) Scientific assessment approach
• Part (2): Focus on Vapour – Overview of Vapour studies and data
• Part (3): Focus on Modern Oral – Overview of Modern oral studies and data

• Where is the category today?
• What does the category need to do to stay relevant and competitive?
• Innovation in liquids and technology
• Future of vaping in the Nicotine category and beyond like caffeine, THC, CBD and nutraceuticals

• Gaining an understanding of what smokers and non-smokers alike are looking for in nico products to better cater to market needs
• Understanding the role of the wide variety of products in the market to identify how these can complement existing nicotine and e-tobacco formats
• Looking at the growth of pouch tobacco and e-cigarette use to understand who these appeal to and how to better leverage the market
• Exploring current innovations to better predict emerging trends and declines
• Discussing possibilities of undoing the stigmas surrounding e-cigarettes to rebuild consumer confidence in the market

• RELX Infinity ENDS
• RELX PRO e-liquid pods
• Adults’ risk perceptions and use intentions
• PMTA quantitative assessment
• Potential population health impact

• Analysing the smokeless and smoke free tobacco market to predict the direction of the industry
• Questioning the role in regulations across the whole nicotine portfolio and how this effects the product to market process
• Transitioning from traditional tobaccos to next-gen nicotine formats effectively to promoto harm reduction and cater to consumer choice
• Onboarding tobacco users to the smokeless product range to cater to smokers’ needs by way of an effective harm reduction strategy

• This presentation will focus upon the contested space that is the regulation of next generation nicotine products -electronic nicotine delivery systems.
• Now in the latter stages of the Pre-Market Tobacco Application process- what does this mean for ENDS companies.
• The need to begin planning for Post Market Surveillance
• The need to begin planning for the loss of products.
• The importance of ensuring that there is up to date evidence with which to challenge the basis upon which PMTA decisions have been made where there is at least a prima-facie case that those decisions have been politically influenced.
• The importance of behavioral data on the impact of reduced availability of ENDS devices within the U.S. market- what happens to those vapers that are using devices and liquids withdrawn from the U.S. market?
• The need to recognise that not all devices are equal in their impact and the need to identify which devices are most impactful with which groups of smokers.
• The Big Vape U.S. study what is it? what will it tell us? when will it start? who will it report to?

• How has the tobacco and e-tobacco industry been affected by the pandemic?
• Compete or Collaborate? How can we navigate the fragmentation of product choice? Is there opportunity to work together to impulse sales cross-category?
• Do we really understand the drivers that make the consumer opt for nico & nico-alternative products?
• Where is the market headed considering being hit with new e-cig regulations and delivery challenges?
• How can we overturn the skeptical attitudes from consumers surrounding certain formats and address concerns that are holding the market back?
• How can we honour consumer choice and listen to their needs?

1. Products – Manufacturers and Product Offerings
2. Markets – USA, Korea, Europe
3. Opportunities – Vape, Nicotine Pouch, HNB, Non-Tobacco Alternatives

• What data behavioural data FDA will expect to receive on an ongoing basis?
• How to design and implement behavioral studies to support continued APPH status
• Outline the opportunities and pitfalls of post-market behavioral studies
• Describe how alliances can protect company resources