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

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12:05 – 1:05 PM 

Clinical Investigations: Sponsor/Investigator Responsibilities and Compliance Issues
Rebecca Jones McKnight, Partner, DLA Piper LLP (US)

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1:05 – 1:15 PM 


1:45 – 3:00 PM 

Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP

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2:15 – 2:30 PM


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

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3:30 – 3:45 PM


3:45 – 5:00 PM

Post Marketing Issues
Michael Chellson
, Principal Consultant, NSF International
Dhanmati Rupnarine, Principal Consultant, NSF International

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