Delegates will enter a draw to win prizes.
Archives: Agenda
Misuse, Misinformation and the Science Media Pipeline
Afternoon refreshments
Chair’s opening remarks
Registration and networking
Tobacco Harm Reduction Potential of the Ploom® System in the U.S.
- The science and evidence demonstrating the Ploom® System is APPH
- A comparison of HPHC exposure with use of the Ploom® System and smoking combustible cigarettes
- Menthol-flavored heated tobacco sticks role in switching
Morning Refreshments & Networking
Bridging the Gap between PMTA Module 5 & 6 Regulatory Expectations and Business Objectives
- Understanding FDA CTP’s Guidance in 2025 and beyond
- Risk: Benefit ratio of human behavior
- Importance of Product Development and early-stage market considerations
Navigating the Regulatory Landscape of ENDS and Nicotine Pouches in the U.S.
- Strategic Considerations for PMTA (Premarket Tobacco Product Application)
- Successfully Submitting Your PMTA
- Managing the Application Process and Post-Market Reporting
- The Role of Risk Assessments in FDA Regulatory Submissions
Postmarket Under the Microscope: A Global Look at Regulatory Expectations for Nicotine Products
- What global regulators are learning from the market: quality concerns, GMP expectations, and the rise of enforcement activity
- The US PMTA lifecycle: What happens after authorization — and how to manage change effectively
- Strategies for building postmarket compliance into your product development from the start
- When things go wrong: dealing with adverse events and meeting FDA’s 15-day reporting expectations