What is FDLI?

Annual Conference
As the premier conference for the food and drug law community, the FDLI Annual Conference addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. The conference provides in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia.
Sessions
Due Diligence: Ensuring Regulatory Control and Compliance Post-Acquisition
(Wednesday, May 17, 3:15pm-4:15pm | Concurrent breakout sessions 2)
Due diligence can uncover regulatory and compliance concerns, and it is important to know how to mitigate your risk. How is your company tracking and remediating issues that have come to light during the due diligence process? How do you ensure that your company won’t be held legally liable for regulatory issues inherited during acquisition? Speakers will address these issues and discuss techniques to determine whether due diligence concerns exist from the start.
- Michael Hidock, Principal Consultant, IQVIA
- Bethany J. Hills, Partner, DLA Piper LLP (US)
- Joshua M. Oyster, Partner, Ropes & Gray LLP
- Moderated by Winston S. Kirton, Partner, BakerHostetler
FDA’s New “Human Foods Program”: How It Will Impact Food Safety Oversight
(Wednesday, May 17, 3:15pm-4:15pm | Concurrent breakout sessions 2)
In January, Commissioner Califf announced a proposed redesign of FDA’s food programs to enhance coordination, prevention, and response activities following the report from the Regan-Udall Foundation. This followed a slate of issues with food safety regulation, including funding, adequate oversight authority, and infant formula safety outbreaks. Are these reforms transformative, or do they not go far enough? What are the potential outcomes for improving food safety, and what are the prospects for industry and public health?
- Susan M. Bond, Vice President, Regulatory & Scientific Affairs, Kerry, Inc.
- Aliza Silver, Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor, & Pensions
- Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest
- Moderated by Sharon Lindan Mayl, Partner, DLA Piper LLP (US)
9:05 AM–9:45 AM |Fireside Chat
(Thursday, May 18)
- Richard Burr, Principal Policy Advisor and Chair, Health Policy Strategic Consulting Practice, DLA Piper LLP (US) and Former US Senator, North Carolina
- David A. Kessler, Former Commissioner, FDA
- Moderated by Christine M. Simmon, President & CEO, FDLI

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