Wednesday, November 30
Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:00 PM
I. Is My Digital Health Product a Medical Device Regulated by FDA?
Gbenga Awotunde, Genentech Inc.
Imein Bousnina, Associate Program Director, US Regulatory Policy, Genentech, Inc.
II. What Regulatory Pathway Applies to My Digital Health Product? What Ae Other Relevant Considerations in Digital Health?
Jeffrey Ballyns, Associate Director, Regulatory Policy, Becton Dickinson (BD)
III. What Post-Marketing Issues Should I Be Considering?
Stephanie Philbin, Partner, Goodwin Procter LLP
IV. What Advertising and Promotion Requirements Apply?
Lisa M. Dwyer, Partner, King & Spalding LLP