Wednesday, November 30
11:00–11:05 AM
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.
12:00–12:15 PM
Break
12:15–1:15 PM
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)
1:15–1:45 PM
Break
1:45–2:45 PM
III. What Post-Marketing Issues Should I Be Considering?
Stephanie Philbin, Partner, Goodwin Procter LLP
2:45–3:00 PM
Break
3:00–3:45 PM
IV. What Advertising and Promotion Requirements Apply?
Lisa M. Dwyer, Partner, King & Spalding LLP