VISE Seminar: Incorporating FDA Regulatory Thinking Into Plans for Medical Devices. Thursday June 11th, 12:10. SC 5326, Refreshments provided at noon.
Title: Incorporating FDA Regulatory Thinking Into Plans for Medical Devices
Speaker: Kenneth J. Holroyd, MD, MBA, Medical Director, Center for Technology Transfer and Commercialization
Medical Device Regulatory Affairs Program, Assistant Vice Chancellor for Research
Date: Thursday, June 11th
Time: 12:10pm start, noon snacks
Place: Stevenson Center 5326
Abstract: Discussion of the utility of thinking about Food and Drug Administration regulations to promote greater success in medical device grant applications, research, development, clinical investigation, and technology commercialization. Sharing information about Vanderbilt’s Medical Device Regulatory Affairs Program, begun last year, which was created to support the faculty in these areas.Note: I have also attached the flyer associated with Medical Device Regulatory Affairs Program (MDRAP), that Dr. Holroyd will speak to us about.
Short Bio: Ken Holroyd is a physician with board certification in anesthesiology, pulmonary medicine, and internal medicine, with training at Johns Hopkins University and the National Institutes of Health. Joining Vanderbilt University in 2005, Ken is Medical Director of the Center for Technology Transfer and Commercialization, and leads the recently created Medical Device Regulatory Affairs Program. Other activities include: participation in the Clinical and Translational Science Award (CTSA) program and the Coordinating Center for the CTSA National Consortium, in the area of public-private partnerships; serving as a Vanderbilt representative on the Board of Directors for Informatics Corporation of America, DigiChart, Cumberland Emerging Technologies, Friends in Global Health, and previously served with LaunchTN, and Acuitec.; clinical care in the operating room as part of the Multi-Specialty Anesthesiology division; teaching the Owen MBA class on the pharmaceutical, biotech, and medical device industries. Before joining Vanderbilt, Ken was Chief Operating Officer of NASDAQ drug development company Genaera Corporation, with publications related to drug development in oncology, ophthalmology, cystic fibrosis, bacterial infections of diabetic foot ulcers, and asthma.
MDRAP information sheet:
