Spotlight: FDA’s Current Approach to Toxicological Risk Evaluation to Inform APPH: A Nonclinical Case Study of Breeze Pro Disposable ENDS

In 2024, the FDA released two key scientific memoranda that shifted their approach to evaluating toxicological risk in ENDS PMTA from a mixture-based to a component-based framework, focusing on individual constituents and their cancer risk profiles. These memoranda established Quantitative Risk Assessment (QRA) as the cornerstone of toxicological risk evaluation in ENDS PMTAs, informing regulatory decisions on whether products are APPH. This presentation will explore the implications of the FDA’s new perspective, discuss strategies for navigating the evolving PMTA regulatory landscape, and use Breeze Pro ENDS chemistry, toxicology, and QRA as a case study.

INTERACTIVE ROUNDTABLES

A unique opportunity to deep dive into the most challenging issues and best practices. Develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. 

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

Roundtable 1) Growth vs. Sustainability: The Food & Beverage Balancing Act

Explore the dynamic interplay between growth and sustainability in the food and beverage industry. Do you believe that rapid expansion and eco-friendly practices can coexist harmoniously?  Where can tech help and data support a sustainable profitable future?

Alex Broadley, Vertical Market Head, Industry Sector, Siemens

Roundtable 2) Food Waste in Focus: Practical Steps to Reducing Food Waste in the Supply Chain 

A collaborative session focused on understanding and addressing the everyday causes of food waste in factories. This round table is designed to help you take informed, achievable steps toward reduction, ranging from fixing internal inefficiencies, removing value chain constraints and where to find overlooked losses.

James Watson, Partner, Argon & Co

 Roundtable 3) Harnessing Gen AI in the Food Supply Chain: A game-changer in waste reduction & emissions

Available for Sponsorship