Ashley Brown
Ashley Brown is a senior clinical toxicologist and pharmacovigilance professional with more than 15 years of experience spanning poison center consultation, post-market surveillance, and regulatory advisory work across FDA-, EPA-, and CPSC-regulated product categories. As Manager of Clinical Toxicology and Pharmacovigilance Officer at SafetyCall International, she leads adverse event signal detection, health hazard evaluation, and toxicological risk assessment for a broad range of consumer, veterinary, and pesticide products. Ashley holds an adjunct faculty appointment at the University of Minnesota College of Pharmacy, where she teaches and serves as Associate Course Director for the toxicology elective. She has presented at national conferences including HCPA, NACCT, AAPSE, and TPSA on topics ranging from post-market surveillance methodology to pesticide safety education. Her work at the intersection of clinical toxicology and regulatory science informs her approach to adverse event data interpretation and evidence-based risk characterization.
Monday Dec 7
Joint Antimicrobial & Pest Management Products Division Program
Registrants often learn what regulators expect only after an enforcement action or a data call-in is already underway. This joint program of HCPA’s Antimicrobial and Pest Management Products Divisions will examine two areas – enforcement and post-market surveillance – where preparation can make a significant difference.
Stop Sale, Start Preparing: Getting Ahead of FIFRA Enforcement and Other Risks: A former EPA enforcement official will provide an overview of recent FIFRA enforcement activity, what companies should learn from it, and how they can better prepare. The session will also offer practical guidance on managing the growing legal risks associated with the use of AI tools in pesticide supply chains and sales.
Before the Data Call-In: Turning Adverse Event Data Into Your Evidentiary Record: California's Department of Pesticide Regulation recently concluded a seven-year investigation into total release foggers that identified 391 injury reports and led to the reevaluation of 42 products across 20 registrants. Using the investigation as a case study, this presentation will examine how regulators interpret spontaneous surveillance data and how the distinction between labeled use and misuse can affect their analysis. The session will also cover how companies can audit, organize, and evaluate their own human and veterinary adverse event data before a data call-in occurs. While the case study focuses on pesticides, the lessons are equally relevant to antimicrobial products.
Speakers:
Ashley Brown, Senior Clinical Toxicologist and Pharmacovigilance, SafetyCall International
Ahna Brutlag, Vice President, Veterinary Services & Senior Veterinary Toxicologist, SafetyCall International & Pet Poison Helpline
Andrew Stewart, Partner, Sidley Austin LLP