BME Seminar Series: Bryan Lisa & Jennifer Paine, Ortho Clinical Diagnostics

Topics in Medical Technology Regulations: Case Studies Highlighting Regulatory Affairs in Practice

Director of Regulatory Affairs & Worldwide Vice President of Regulatory Affairs, Ortho Clinical Diagnostics franchise of Johnson & Johnson

Abstract:

The University of Rochester Biomedical Engineering Department and the Clinical & Translational Science Institute present the fourth and final seminar in a series providing an overview of FDA medical device regulation, focusing on how the regulatory path can influence design and testing of medical technology. Each seminar will build on previous discussions, but are designed to offer stand-alone content. For this seminar, the role of the regulatory professional in industry will be explored. Presenters Bryan Lisa, RAC, and Jennifer Paine, RAC, from the Ortho Clinical Diagnostics franchise of Johnson & Johnson will share information on real-life scenarios in regulatory affairs, with details on regulatory filings and the true cost of a submission, including actual FDA examples and case studies.