Machine Learning for Regulatory Attorneys and English Majors
Tired of hearing technical experts talk about machine learning algorithms and not understanding what they are saying? This webinar is intended for regulatory attorneys advising clients developing algorithms for regulated or nearly regulated uses. It will provide a broad understanding of the machine learning models including supervised, unsupervised, and deep learning. The webinar will also cover the importance of and challenges in mitigating explicit and implicit racial bias negatively impacting Blacks and ethnic minority groups in algorithmic design. The webinar will include a case study using machine learning on data from FDA on 510(k) summaries and include the use of natural language processing (i.e., how Alexa understands humans).
, Assistant Director for Medical Imaging and Digital Health, Division of Imaging, Diagnostics and Software Reliability (DIDSR), OSEL, CDRH, FDA
BRADLEY MERRILL THOMPSON is a shareholder in the national law firm of Epstein Becker & Green, P.C., in the firm’s Washington DC office. There he counsels software, medical device, and drug companies on a wide range of FDA regulatory issues, and leads the firm’s AI practice. For trade associations, Mr. Thompson has served as counsel to AdvaMed and the Continua Health Alliance, as General Counsel to the Combination Products Coalition, mHealth Regulatory Coalition, the Clinical Decision Support Coalition, and AI Startups in Health Coalition. He has taught Food & Drug Law at Indiana University School of Law and has served as Co-Chair of the Food & Drug Law Committee in the American Bar Association and the Medical Device Committee of FDLI. He received his BA, and an MBA from the University of Illinois at Urbana-Champaign and his JD from the University of Michigan Law School. Mr. Thompson also is presently completing a Masters in Applied Data Science at the University of Michigan.
JANA G. DELFINO, PhD, is the Assistant Director for Medical Imaging and Digital Health in FDA’s Division of Diagnostics, Imaging, and Software Reliability in the Office of Science and Engineering Laboratories. An engineer by training, Dr. Delfino received her BS in Agricultural Engineering from the University of California at Davis and her PhD in Biomedical Engineering from the Georgia Institute of Technology/ Emory University where her area of study focused on novel applications of magnetic resonance imaging. Dr. Delfino joined FDA in 2009 following a postdoctoral fellowship in the Division of Radiology at Emory University Hospital. During her time at FDA, Dr. Delfino has served in various roles at the FDA within both the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER), including as a policy analyst within CDER’s Biomarker Qualification Program (BQP) and as a lead reviewer, branch chief, and division director within CDRH’s Division of Radiological Health.
Summer Learning Series
The Summer Learning Series brings the top thinkers and leaders of our industry to speak on a broad array of topics essential to the food and drug law professional, covering matters that perhaps we all wish we knew a bit more about as we work and converse with clients, colleagues, and the FDA. Join us this June through July and build foundation in the following subjects: