DLA Piper takes great pride in its strategic affiliation and membership with FDLI. DLA Piper actively participates in 9 distinct FDLI Committees, and has hosted and will continue to host various programs and receptions at its offices, including the Food Advertising, Labeling, and Litigation Conference: For the Food and Dietary Supplement Community and Tobacco and Nicotine Product Regulatory Science Symposium.

What is FDLI?

The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law. As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation.

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

Strategic guidance for a complex regulatory environment

In the highly regulated FDA landscape, companies operating in the life sciences, food and dietary supplement industries need a tactical legal partner with a nuanced approach to the complex issues at hand. Our team provides a global perspective, offering guidance on regulations, compliance and strategy through a pragmatic and patient-centric lens. Moreover, when your innovation calls for practical regulatory solutions, we can support you in navigating the gray areas.