Pre-Conference Workshop | December 5, 2018

Assessing the Safety of ENDS in a Regulatory 
and Product Stewardship Framework

Product stewardship is the understanding, controlling and communicating of a product’s health and safety throughout its life cycle.  Whether or not ENDS companies anticipate submitting a PMTA in 2022, having a solid product stewardship program is important for sustaining product innovation and marketplace.  In other industry sectors, product stewardship programs have evolved beyond product safety and regulatory compliance to corporate responsibility and sustainable product innovation. 

Taking place Wednesday, December 5, this half-day workshop will focus on research strategies and testing methods to evaluate the safety of ENDS products in the context of the Pre-Market Tobacco Application (PMTA), as well as in the framework of best practices for product stewardship.  Scientists and industry representatives will address through the following presentations, basic elements of a product stewardship program and approaches to evaluate product health impacts along the continuum of risk of tobacco products in a regulatory context.

View the Complete Workshop Agenda

Coordinated By - Amy Madl, Ph.D., DABT and Autumn Bernal, Ph.D., of Cardno ChemRisk

Presentation topics to include:

  • Product stewardship and the PMTA – Product safety, regulatory compliance and beyond
  • Human health risk assessment – Integrating non-clinical and clinical testing to evaluate human health impacts
  • Product testing and toxicology assessments – From product screening to experimental toxicity testing
  • Clinical research – Consumer patterns, pharmacokinetics, biomarkers, and health effects in the context of demonstrating impact in the continuum of risk
  • Case studies of global product stewardship programs – Takeaways for the ENDS industry

Participants of the workshop will learn more about:

  • The basic components of a product stewardship program
  • Best practices of product stewardship executed by other industry sectors
  • Strategies to integrate and bridge non-clinical and clinical ENDS research for the PMTA across products - including different e-liquid flavors
  • Screening approaches to identify products for PMTA submission
  • Information that is needed up and down the supply chain to support safety and regulatory compliance
  • Study design considerations to leverage clinical and non-clinical testing for a human health risk assessment

Book Your Combined Ticket Here | ENDS US 2018 Conference + Workshop

* You cannot participate in the workshop without registering for ENDS US 2018*