Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA
January 30, 2024 | Virtual Course
Subject to change
All times are in Eastern Time
2024 Curriculum Advisor:
Renee Beaver, Director, Corporate Counsel, Legal Affairs, Otsuka America Pharmaceutical, Inc.
Tuesday, January 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?
Laura Bailis, Senior Counsel, Regulatory Law, Johnson & Johnson
12:00–12:15 PM
Break
12:15–1:15 PM
II. What Regulatory Pathway Applies to My Digital Health Product? What Are Other Relevant Considerations in Digital Health?
Kelliann H. Payne, Partner, Hogan Lovells US LLP
1:15–1:45 PM
Break
1:45–2:45 PM
III. What Post-Marketing Issues Should I Be Considering?
Christine P. Bump, Principal, Penn Avenue Law & Policy
2:45–3:00 PM
Break
3:00–3:45 PM
IV. What Advertising and Promotion Requirements Apply?
Bradley Merrill Thompson, Partner, Epstein Becker & Green, PC