Overview
This panel will give an overview of the process of contacting and engaging with the FDA while working in law firms or FDA-regulated companies. Speakers will explain the different FDA centers and offices, how to contact and plan a meeting with them, communication strategies, and how to make the most of your time with the agency. A reception will follow the panel discussion. This program is limited to FDLI members who are a part of NFDL, summer associates, and student members.
Speakers
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker LLP
Erica M. Katherine, Ombudsman, Office of Regulatory Affairs, FDA
William (Bill) McConagha, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Jessica Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences LLC
Moderated by Avia M. Dunn, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
AVIA DUNN is a partner at Skadden, Arps, Slate, Meagher & Flom LLP where her practice focuses on internal and congressional investigations, health care regulatory enforcement actions, and complex civil and criminal litigation. Dunn frequently counsels pharmaceutical and medical device clients on Food and Drug Administration (FDA) regulatory strategy, corporate compliance programs, product promotion, product recalls and litigation defense strategies in response to actions involving federal and state fraud and abuse laws. In addition, Dunn conducts pre- and post-transaction reviews in connection with transactions in the life sciences industry. Dunn also is active with the firm’s diversity leadership initiatives and serves on Skadden’s women and family diversity committees. In addition, Dunn has represented pro bono clients in domestic violence proceedings.
JESSICA L. ZELLER is Vice President, Quality, Regulatory, and Public Affairs Counsel at Edwards Lifesciences based out of Irvine, CA. She routinely counsels on global medical device regulatory compliance matters and quality systems concerns, including interacting with government regulators. She was previously FDA’s inaugural ORA Ombudsman, focusing on problem-solving with respect to FDA’s field offices, including inspections, imports, and other agency processes and procedures. Additionally, she has served as the Deputy Directory of Compliance and Enforcement for FDA’s Center for Tobacco Products, as a litigation attorney in FDA’s Office of Chief Counsel, as the lead FDA lawyer for Procter & Gamble, and is the co-editor on an upcoming FDLI publication about How to Work with the FDA. Zeller holds a JD/MA (Bioethics) from University of Virginia and a BS (Biology) from Xavier University.July, 21, 2022
4:45–6:30 PM ET
Agenda
4:45-5:00 PM | Check-In
5:00-5:45 PM| Panel Discussion
5:45-6:30 PM | Reception
The panel discussion will be indoors, and the reception will be outdoors. In the event of inclement weather, the reception will be indoors.
This program is limited to FDLI members who are a part of NFDL, summer associates, and student members. This complimentary program includes a light reception. Please register by July 18 to reserve your spot.
New to Food and Drug Law Group
The New to Food and Drug Law Group (NFDL) offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
Location
Conference Location
Skadden, Arps, Slate, Meagher & Flom LLP
Rooftop
1440 New York Ave NW
Washington, DC 20005
Program Host
