Connect Conference & Show Floor Educational Sessions

View, browse and sort the list of Connect Conference sessions and show floor programming by pass type, track, and format. Please note, all Connect Conference delegates have access to InformEx Connect and CPhI Connect programming. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

To learn more about the Connect Conference program, click here.

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  • Jonathan S. HelfgottAdjunct Professor, Johns Hopkins University Graduate Program in Regulatory Science & Former Acting Associate Director, Office of Scientific Investigations, CDERJohns Hopkins

    Jonathan S. Helfgott is currently the Director of Global Regulatory Affairs at Stage 2 Innovations and Coordinator for the Regulatory Science Graduate Program at Johns Hopkins University. Prior to joining Stage 2 Innovations in early 2015, Mr. Helfgott was formerly the Associate Director for Risk Science, within the Office of Scientific Investigations at FDA's Center for Drug Evaluation & Research (CDER). Prior to joining CDER in 2010, Mr. Helfgott worked at the FDA's Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO). Mr. Helfgott specialized in Computerized Systems used in FDA regulated Clinical Investigations. Mr. Helfgott has also served as an Adjunct Professor for the JHU M.S. Regulatory Science program since 2011, teaching: Clinical Development of Drugs & Biologics, International Regulatory Affairs, Validation in Biotechnology, & Biomedical Software Regulations. 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 the Washington Post and in Peer Reviewed Journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, FDLI Update, Touch Briefings, and Medical Device and Diagnostic Industry. Mr. Helfgott also continues to lecture and be involved with various regulatory professional organizations such as DIA, CTTI, ACRP, RAPS, SoCRA, SCDM, AdvaMed, CHI, CBI, FDANews, and others, and has also lectured at academic institutions such as Stanford University School of Medicine, University of Miami School of Medicine, Northwestern University, Columbia University, University of Colorado Denver Medical School, University of Pittsburgh Medical Center, Georgetown University, Children's Hospital of Philadelphia, Shriners Hospitals, 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 M.S. in Bioscience Regulatory Affairs from Johns Hopkins University and his B.S. in Cell Biology and Molecular Genetics from the University of Maryland College Park.


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