Speakers
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.
Darrell R. Abernethy, MD, PhD
Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER, FDA, United States
Dr. Abernethy has published more than 200 original papers in the general areas of geriatric clinical pharmacology and prediction of adverse drug effects. Following academic positions at Tufts, Baylor College of Medicine, Brown University, and Georgetown, he was in the National Institute on Aging Intramural Research Program, until he joined the FDA in his current position 5 years ago.
Keith K. Burkhart, MD
Senior Advisor for Medical Toxicology, DARS, OCP, OTS, FDA, United States
Dr. Burkhart received his medical toxicology training at the Rocky Mountain Poison Center in Denver. He received his Emergency Medicine training at the University of Cincinnati. He is the former Medical Director of the Penn State Poison Center. Clinical care has been provided at the PinnacleHealth Hospital. He is a co-editor of Critical Care Toxicology. He performs mechanistic-based biological plausibility consults for drug safety issues using cheminformatic and bioinformatic tools. Natural Language Processing is used to analyze the OVERDOSAGE Section of drug labels. Data mining is used to analyze real world evidence.
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