Jonathan S. Helfgott is a Consumer Safety Officer for the FDA in the Center for Drug Evaluation & Research (CDER), within the Division of Scientific Investigations. Prior to joining CDER in 2010, Mr. Helfgott worked at the Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO). Mr. Helfgott specializes in Computerized Systems used in FDA regulated Clinical Investigations. Mr. Helfgott is the Co-Editor of the Food and Drug Law Institute’s 2009 Publication, “Biomedical Software Regulation.” Mr. Helfgott has also been published in Peer Reviewed Journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, and Medical Device and Diagnostic Industry. Mr. Helfgott has also lectured for organizations such as DIA, ACRP, RAPS, SOCRA, SCDM, AdvaMed, CHI, CBI, and FDA News as well as academic institutions such as Northwestern University, Columbia University, Johns Hopkins University, University of Colorado Denver Medical School, University of Pittsburgh Medical Center, Georgetown University, Stanford University School of Medicine, and NIH’s National Heart Lung and Blood Institute.     [ Click for More ]

Jonathan S. Helfgott is a Consumer Safety Officer for the FDA in the Center for Drug Evaluation & Research (CDER), within the Division of Scientific Investigations. Prior to joining CDER in 2010, Mr. Helfgott worked at the Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO). Mr. Helfgott specializes in Computerized Systems used in FDA regulated Clinical Investigations. Mr. Helfgott is the Co-Editor of the Food and Drug Law Institute’s 2009 Publication, “Biomedical Software Regulation.” Mr. Helfgott has also been published in Peer Reviewed Journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, and Medical Device and Diagnostic Industry. Mr. Helfgott has also lectured for organizations such as DIA, ACRP, RAPS, SOCRA, SCDM, AdvaMed, CHI, CBI, and FDA News as well as academic institutions such as Northwestern University, Columbia University, Johns Hopkins University, University of Colorado Denver Medical School, University of Pittsburgh Medical Center, Georgetown University, Stanford University School of Medicine, and NIH’s National Heart Lung and Blood Institute. Mr. Helfgott co-developed the Software Education Program for the CDRH Staff College through the Medical Device Fellowship Program. Prior to joining FDA in May 2006, Mr. Helfgott conducted genetic research using micro-array technology at the NIH’s National Institute on Aging. Mr. Helfgott received his MS in Bioscience Regulatory Affairs from Johns Hopkins University and his BS in Cell Biology and Molecular Genetics from the University of Maryland College Park.