FDLI Enforcement, Litigation, and Compliance Conference 2025

Dennis Gucciardo and Ariel Seeley will be presenting during the Food & Drug Law Institute’s (FDLI’s) Enforcement, Litigation, and Compliance Conference. This annual event brings together industry, regulators, attorneys, litigators, academics, and consultants and other stakeholders to discuss trends and issues in enforcement and compliance.

Ariel Seeley will moderate the panel Smart Compliance, Smarter Enforcement: AI in Industry and at the Food and Drug Administration (FDA) on Thursday, December 4. This discussion will cover artificial intelligence (AI) use, not only for manufacturers and developers but also from within the agency itself. Attendees will gain new insights on how the Elsa tool is being deployed and how they should understand AI use on both sides of the regulatory equation.

On Friday, December 5, Dennis will present as part of the panel Beyond the Rule: What to Watch in FDA’s QMSR Transition. This talk will focus on the incorporation of ISO 13485 requirements into the Quality Management System Regulation (QMSR). Dennis will provide actionable advice on transitioning from the current regulatory framework and an understanding of which areas of the rule may see further clarification in the future.