Archives: Agenda

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. 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 40 minutes, and delegates may attend up to 2 roundtables.

 

Roundtable 1: Enforcement and Illicit Products – State of the Union Update and Moving Forward

Angela Ho-Chen, Managing Counsel – Regulatory, Reynolds American

 

Roundtable 2: Navigating Non-Clinical: Strategic Insights and Considerations for Nicotine Pouch Testing

HPHC: Testing Considerations

  • The selection of an appropriate HPHC test list should be guided by a thorough understanding of the product’s constituent sources (e.g., plant-based or synthetic) and relevant chemical properties. Consideration should also be given to compounds that would only be present due to combustion or pyrolysis mechanisms.

Stability Studies: Optimize Your Study Duration and Testing Intervals

  • Testing intervals and overall study duration should be determined based not only on the product’s intended shelf life but also on an assessment of inherent risks associated with its composition (e.g., susceptibility to microbial growth). Leveraging existing knowledge can help optimize study design and ensure robust stability assessments.

Extractables & Leachables: Identify and Mitigate Material-Related Risks

  • Evaluating extractables and leachables is critical to ensuring the safety and quality of pouch materials and packaging. Identifying potential impurities or contaminants that could migrate into the product allows manufacturers to proactively mitigate risks and maintain product integrity.

Dissolution Testing Applications: How to Strengthen Your Regulatory Strategy

  • Nicotine release profiles derived from dissolution testing can be influenced by various product-specific factors, including pH modifiers, particle size, and pouch material. Comparing these release profiles across tobacco products can provide valuable insights into whether a new product may present different public health considerations.

Valerie Schwartz, Regulatory Affairs Manager, Accorto Regulatory Solutions