Agenda

Agenda Subject to Change
All times are in Eastern Time

2024 Curriculum Advisor:
Steven S. Tjoe, Partner, Goodwin Procter LLP

Tuesday, April 9

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
Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett

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
Sarah Blankstein, Counsel, Ropes & Gray LLP

11:35 AM–12:35 PM
Networking Lunch

12:35–1:55 PM
Clinical Investigations
Anisa Mohanty, Of Counsel, DLA Piper LLP (US)

1:55–2:10 PM
Networking Break

2:10–3:30 PM
Premarket Notification 510(k) and De Novo Requests
Seth Olson, Associate, Latham & Watkins LLP

3:30–3:45 PM
Networking Break

3:45–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Kristin Zielinski Duggan, Partner, Hogan Lovells US LLP

Wednesday, April 10

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

8:35–9:35 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Cybil Roehrenbeck, Partner, Hogan Lovells US LLP

9:35–9:50 AM
Networking Break

9:50–11:05 AM
Post Marketing Issues
Benjamin K. Wolf, Senior Associate, Alston & Bird LLP

11:05–11:20 AM
Networking Break

11:20 AM–12:20 PM
Manufacturing and Quality System (QS) Regulation
Lisa El-Shall, Senior Director, EAS Consulting Group

12:20–1:20 PM
Networking Lunch

1:20–2:30 PM
Enforcement and Compliance
Michael Purcell, Associate, Ropes & Gray LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP

2:30–2:45 PM
Networking Break

2:45–3:45 PM
Promotion and Advertising
Carolina M. Wirth, Of Counsel, Hall, Render, Killian, Heath & Lyman P.C.

3:45–4:00 PM
Networking Break                                     

4:00–5:00 PM
International Issues
Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC

5:00 PM
Adjournment