The Keynote Address will be delivered by Dr. Sharon-Lise T. Normand of Harvard University. Dr. Normand is a professor of health care policy in the Department of Health Care Policy at Harvard Medical School and the Department of Biostatistics at the Harvard School of Public Health. She also serves as Director of the Massachusetts Data Analysis Center (Mass-DAC). The title of her talk is Statistical Methods for Assessing the Comparative Safety and Effectiveness of Medical Devices: Distributed Networks, Auxiliary Data Sources, and Learning Curves.