Tuesday, April 11
8:00–8:30 AM
Registration and Continental Breakfast
8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
8:35–9:35 AM
Overview of Medical Device Law and Regulation and Organizational Structures
Steven S. Tjoe, Partner, Goodwin Procter LLP
9:35–9:50 AM
Networking Break
9:50–10:35 AM
Combination Products
Laura S. Dona, Associate, Arnall Golden Gregory LLP
10:35–10:50 AM
Networking Break
10:50–11:35 AM
Digital Health
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
11:35 AM–12:35 PM
Networking Lunch
12:35–1:55 PM
Clinical Investigations
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker, LLP
1:55–2:10 PM
Networking Break
2:10–3:30 PM
Premarket Notification 510(k) and De Novo Requests
Jemin Dedania, Director of Regulatory Sciences, Hogan Lovells US LLP
3:30–3:45 PM
Networking Break
3:45–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Judith O’Grady, Partner, Troutman Pepper Hamilton Sanders LLP
Wednesday, April 12
8:00–8:30 AM
Registration and Continental Breakfast
8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
8:35–9:35 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Preeya Noronha Pinto, Partner, King & Spalding LLP
9:35–9:50 AM
Networking Break
9:50–11:05 AM
Post Marketing Issues
Marc J. Scheineson, Partner, Alston & Bird LLP
11:05–11:20 AM
Networking Break
11:20 AM–12:20 PM
Manufacturing and Quality System (QS) Regulation
Kristen Grumet, Senior Vice President, Greenleaf Health, Inc.
12:20–1:20 PM
Networking Lunch
1:20–2:30 PM
Enforcement and Compliance
Avia Dunn, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
2:30–2:45 PM
Networking Break
2:45–3:45 PM
Promotion and Advertising
Mahnu Davar, Partner, Arnold & Porter LLP
3:45–4:00 PM
Networking Break
4:00–5:00 PM
International Issues
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
5:00 PM
Adjournment