Anthony DeMaria, MD Founding Director Sulpizio Cardiovascular Center, UCSD Learning Objectives Understand the need for collaboration between innovator and industry Learn about the concern of conflict of interest Learn about the rules and regulation of conflict of interest Learn how to deal with bias related to the conflict of interest
Roxana Mehran, MD Professor of Medicine, Icahn School of Medicine, Mount Sinai Learning Objectives Understand how digital health, precision medicine, and big data impact the guideline Learn about the importance of expediting the guideline Learn about the importance of using digital technology in the randomized clinical trial Understand the risk of bias assessment
Lori Ashby Director, Division of Policy and Evidence Review, Centers for Medicare and Medicaid Services (CMS) Learning Objectives Understand the background of Medicare establishment and its goal Learn about Medicare national coverage process Understand the role of MEDCAC Learn about coverage with evidence development Learn about the IDE coverage and the clinical trial policy Learn […]
Marco Cannella, PhD Team Lead for Cardiac Ablation, Mapping & Imaging Devices, Office of Product Evaluation & Quality, FDA Learning Objectives Learn the regulatory elements for diagnostic devices Understand the device hazard analysis Understand the regulatory implication for clinical claim Learn the elements needed in preparing for the marketing application
Morton Kern, MD Chief of Medicine, VA Long Beach Professor of Medicine, University of California Irvine Learning Objectives What is involved with Cardiac Cath When is it indicated or contraindicated What are the anticipated results What common therapeutic procedures are available to the patient in the cath lab
