Terri L. Spanogle
Ms. Spanogle has many years of experience managing complex regulatory and scientific projects. She provides an extensive range of regulatory services such as new active ingredient and new product registrations, registration review, regulatory strategy, and general registration support for pesticides and plant growth promotion/protection products.
Prior to joining SciReg, Ms. Spanogle was a Senior Toxicologist with FMC Corporation (formerly Cheminova, Inc.) where she managed and contributed to the development of new active ingredient registration submission data packages, toxicological data, human health risk assessments, “white paper” position documents, scientific rationales, study waivers, and product defense strategies. She has extensive experience with study design, study monitoring, and evaluating and interpreting data of various types, especially mammalian toxicological studies. Ms. Spanogle also conducts site visits to testing facilities for inspections, data audits, observation of critical study phases, and evaluation for compliance with the GLP regulations.
Ms. Spanogle provides data gap analysis for pesticides by evaluating existing toxicology study reports for compliance with applicable guidelines (OPPTS, OECD) and develops strategies to address study deficiencies and regulatory concerns. She has experience preparing OECD toxicology study summaries and EU Dossiers and has managed data development and responses to EPA’s Endocrine Disruptor Screening Program (EDSP) Tier 1 test orders, which include Other Scientifically Relevant Information (OSRI), conduct of Tier 1 assays, preparation of study profiles (DERs) and DESTs, and weight of evidence analyses. Ms. Spanogle has experience interacting with regulatory agencies (EPA, PMRA) and participating in various task forces and industry groups.
Ms. Spanogle earned her bachelor of science degree in life sciences from The Pennsylvania State University.