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Biographical Sketch
Dr. Nelson is a clinical pharmacist by background and initial training. He received his B.S. in pharmacy from Brooklyn College of Pharmacy in 1974, then completed an ASHP accredited Residency in Hospital and Clinical Pharmacy at the University of Connecticut Health Center. In 1975, Dr. Nelson accepted a commission in the U.S. Public Health Service, and served at the National Institutes of Health's Clinical Center. He transferred to the Food & Drug Administration’s Division of Neuropharmacological Drug Products in 1977. While on active duty, Dr. Nelson completed both a Master's in Science (in the Administration of Science & Technology), from George Washington University, and a Ph.D. in epidemiology from the University of Minnesota. He conducted his thesis research at the Mayo Clinic. At the FDA, he held multiple positions in new drug review, drug abuse liability assessment and CSA scheduling, epidemiology, and post-marketing surveillance, with an intervening stint to found and direct the Center for Drug’s Staff College. In his most recent FDA position as Associate Director (Epidemiology) he lead the re-engineering of the post-marketing surveillance program for human drugs, including utilization of relevant ICH initiatives, a comprehensive regulations rewrite (aka The TOME), full process re-engineering, and the construction of a new computer system (AERS) for spontaneous adverse drug reactions. Dr. Nelson retired from the U.S. Public Health Service in February 1998 with the rank of Captain. He is currently President of RCN Associates, Inc., an independent consulting firm in global drug safety, postmarketing surveillance, pharmacoepidemiology, therapeutic risk management, regulatory strategy, drug abuse liability assessments and drug scheduling, Good Pharmacovigilance Practices (GPVP), forensic epidemiology, and regulatory affairs. He also is CEO of NLabel, Inc. an emerging software firm specializing in regulatory document exchange, industry oriented product-labeling solutions and drug safety support systems. |
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Last modified: 10/24/03 |
