Supported by Society of Toxicologic Pathology and Safety Pharmacology Society
Moderated by Kara Polhamus and Sam Tadepalli
Date and Time: February 12, 2020 at 11:00 am (EST)
Description: This webinar will provide an overview of safety assessment of metabolites in drug development. The speaker will discuss relevant guidance documents and will describe important considerations for the safety assessment of drug metabolites, including type of studies required and timing of submission to regulatory Agencies. This topic has evolved over the last few years and the speaker will incorporate FDA recent case studies that will provide participants insight into the regulatory decision-making process regarding this topic. Examples will include unique human metabolites, disproportionate human metabolites, metabolites that are acyl glucuronides, and examples of safety assessment of drug metabolites for severe, debilitating, and life-threatening (SDLT) conditions.
Speaker: Carol M. Galvis, PhD, Lead Pharmacologist, US Food and Drug Administration
Dr. Galvis completed her doctorate degree in pharmacology at the University of Virginia in Charlottesville, Virginia. She continued working as a research associate at the University of Virginia before joining the FDA. Dr. Galvis joined the FDA in 2008 as a pharmacologist in the Office of Compliance, Division of Scientific Investigations (DSI). In this position, she conducted pre-marketing bioresearch monitoring inspections (GLP and Bioequivalence) of a number of laboratories and CROs.
Dr. Galvis is currently a Pharm/Tox Team Leader in the Office of New Drugs (OND), Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). Previously, Dr. Galvis served as a Pharm/Tox reviewer in DPARP for over five years, where she evaluated scientific submissions for drugs and biologics. Dr. Galvis participates in a number of committees within the pharm/tox community in OND as well as outside working groups.
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