Please find the session links next to their corresponding agenda item.
Wednesday, November 17
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
Enter this session: https://fdli.zoom.us/j/87594516306
12:05 – 1:05 PM
Clinical Investigations: Sponsor/Investigator Responsibilities and Compliance Issues
Rebecca Jones McKnight, Partner, DLA Piper LLP (US)
Enter this session: https://fdli.zoom.us/j/87594516306
1:05 – 1:15 PM
Break
1:45 – 3:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP
Enter this session: https://fdli.zoom.us/j/86346828486
2:15 – 2:30 PM
Break
2:30 – 3:30 PM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Michael M. Gaba, Shareholder, Polsinelli PC
Enter this session: https://fdli.zoom.us/j/81094071996
3:30 – 3:45 PM
Break
3:45 – 5:00 PM
Post Marketing Issues
Michael Chellson, Principal Consultant, NSF International
Dhanmati Rupnarine, Principal Consultant, NSF International
Enter this session: https://fdli.zoom.us/j/84448579574