Why Attend?

Agenda
CLE

FDLI’s 2020 Annual Conference Goes Virtual!

FDLI is excited to provide the key industry updates and the opportunity to connect with the food and drug law community that you have come to expect from the Annual Conference, just in a virtual format.  While we will miss seeing each other in person, a virtual format allows the whole food and drug law community to participate regardless of safety concerns, location, time zone, or budget constraints.  

We look forward to hosting an array of experts from the federal government, industry, the private bar, non-profits, patient and consumer advocates, and academia over the span of three shortened days to address the complex legal, regulatory, compliance, and policy issues currently impacting all facets of FDA-regulated industry. Please note that all tobacco topics will be covered in the Tobacco Conference also being held in October.

Keynote Address
Stephen M. Hahn, Commissioner of Food and Drugs, FDA

Conference Highlights: 

  • Hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency and the impacts COVID-19 has had on priorities moving forward
  • Gain in-depth knowledge of each FDA Center by attending consecutive Center Director sessions scheduled to maximize attendee participation
  • Join high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding in the post-COVID era
  • Select from over 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues
  • Learn from more than 100 well-known officials and experts
  • Hear about the Top Cases in Food and Drug Law
  • Network and build relationships with seasoned legal, regulatory, compliance, policy, and government professionals

Key FDA Speakers:

  • Mark Abdoo, Associate Commissioner for Global Policy and Strategy, Office of the Commissioner, FDA
  • Amy P. Abernethy, Principal Deputy Commissioner, Office of the Commissioner, FDA
  • Stacy Cline Amin, Chief Counsel, FDA
  • Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research, FDA
  • Matthew Diamond, Chief Medical Officer for Digital Health, CDRH, FDA
  • Elizabeth Dickinson, Senior Deputy Chief Counsel, Office of the Commissioner, FDA
  • Andrea C. Furia-Helms, Director, Patient Affairs Staff, Office of the Commissioner, FDA
  • Stephen M. Hahn, Commissioner of Food and Drugs, FDA
  • Maarika Kimbrell, Deputy Director, Office of New Drug Policy, CDER, FDA
  • Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA 
  • Sharon L. Mayl, Senior Advisor for Policy, OC, FDA
  • Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA 
  • Judy A. McMeekin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA
  • Theresa Michele, Director, Office of Nonprescription Drugs, CDER, FDA
  • Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
  • Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
  • Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
  • Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA
  • Julia C. Tierney, Chief of Staff, CBER, FDA
  • Francisco Vicenty, Case for Quality Program Manager, Office of Compliance, CDRH, FDA

Last Year’s Attendees

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FDA Officials
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Manufacturer Representatives
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Expert Speakers
  • Food and Drug Attorneys
  • In-House Counsel
  • Senior Regulatory and Policy Professionals
  • Government Officials
  • Compliance Officers and Counsel
  • Food and Drug Industry Consultants
  • Regulatory Affairs Professionals
  • Government Affairs Professionals
  • Chief Safety Officers
  • Academics
  • Consumer Advocates
  • Patient Advocates 
  • Business Development Professionals
  •  Global Strategy Professionals 
  • Venture Capitalists 
  • Corporate Planning Staff

70+ Years of FDLI Serving the Food and Drug Community

Sponsorship Opportunities

Sponsorship opportunities are available. Please let us know if you would like more information

 

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Exhibitor

 

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Planning Committee

Co-Chairs

 

James Czaban
Partner, Loeb & Loeb LLP

 

Adora Ndu
Vice President, Regulatory Affairs, Policy, Research, Engagement (PRE) & Reg International, BioMarin Pharmaceutical Inc.

Committee

Wade Ackerman, Partner, Covington & Burling LLP
David Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Jeff Chasnow, Senior Vice President and Associate General Counsel, Pfizer, Inc.
Sandra Eskin, Project Director, Food Safety, Pew Charitable Trusts
Azim Chowdhury, Partner, Keller and Heckman LLP
Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation, University of Maryland Carey School of Law
Jonathan Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Erika Lietzan, Associate Professor, University of Missouri-Columbia School of Law
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization 
Meredith Olearchik, Vice President and Associate General Counsel, Intellectual Property, Marketing and Food Law, Campbell Soup Company
Suzan Onel, Partner, Kleinfeld, Kaplan & Becker LLP
Stuart Pape, Shareholder, Polsinelli
Lauren Roth, Acting Associate Commissioner for Policy, Office of the Commissioner, FDA
Deborah Shelton, Partner, Arent Fox LLP
David Spangler, Senior Vice President, Policy and General Counsel, Consumer Healthcare Products Association (CHPA)
Marta Villaraga, Principal, Exponent, Inc.
Armando Zamora, Senior Advisor to the Associate Commissioner for Partnerships & Policy, Office of Regulatory Affairs, FDA

 

Call For Proposals

FDLI and the Conference Planning Committee thanks those who participated in the Call for Proposals this Fall. The input received from industry stakeholders helps us plan a timely program.