The premier conference for the food and drug law community, the FDLI Annual Conference addresses every product category regulated by FDA.
Conference Highlights:
- Hear FDA’s 2018 strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency
- Join more than 800 colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
- Select from nearly 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 law, regulatory, compliance, marketing/advertising, and management professionals
FDA Speakers:
- Scott Gottlieb, Commissioner of Food and Drugs, FDA
- Rebecca K. Wood, Chief Counsel, FDA
- Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis, FDA
- Peter W. Marks, Director, Center for Biologics Evaluation and Research (CBER), FDA
- Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA
- Jeffrey E. Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA
- Steven M. Solomon, Director, Center for Veterinary Medicine (CVM), FDA
- Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER), FDA
- Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA
Hot Topics:
- International Harmonization Efforts
- First Amendment and the Regulatory Landscape
- Food Safety Modernization Act: Implementation Update
- Modified Risk Tobacco Products
- Data Integrity and Medical Products
- Use of Real World Evidence for Drugs and Devices
- 21st Century Cures Update
- Changing Environment of FDA Inspections
- Regulation of Medical Devices and 3-D Printing
- Evolving Regulatory Pathways
- Regenerative Medicine
- Regulation of Cell-Based Meat and Other Modified Foods
- Digital Health Regulation
- Cannabis and FDA-Regulated Products
Wednesday, May 2
5:30-7:00 PM | Out-of-Towners Reception
JW Marriott Hotel-Penn Avenue Terrace
Thursday, May 3
8:00–9:15 AM | Registration and Continental Breakfast | Atrium
11:00–11:30 AM | Coffee and Networking Break | Atrium
11:30–12:20 PM | Breakout Sessions
2:00–2:10 PM | Transition
2:10–3:25 PM | Breakout Sessions: FDA Center Directors
Hear directly from each of FDA’s Center Directors and learn about the latest policy developments, enforcement actions, and priority initiatives for 2018. A panel including multi-stakeholder perspectives will follow, along with time for questions from the audience.
3:25–3:50 PM | Coffee and Networking Break | Atrium
3:50–4:50 PM | Breakout Sessions
4:50–5:00 PM | Transition
Friday, May 4
8:00–8:30 AM | Breakfast | Atrium
10:00–10:30 AM | Coffee and Networking Break | Atrium
10:30–11:20 AM | Breakout Sessions
11:20–11:30 AM | Transition
11:30–12:20 PM | Breakout Sessions
1:30–1:35 PM | Transition
1:35-2:20 PM | Breakout Sessions
2:20–2:30 PM | Transition
4:15 PM | Conference Adjournment
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Sponsorship Opportunities
Sponsorship opportunities are available. Take a look at our brochure, and please let us know if you would like more information.
2018 Planning Committee
Co-Chairs
Carla Cartwright
Director, Federal Affairs, Johnson & Johnson
Neil DiSpirito
Of Counsel, Ballard Spahr LLP
Committee Members
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Martin Hahn, Partner, Hogan Lovells LLP
Lori Hirsch, VP of Regulatory Compliance and External Engagement, Bristol-Myers Squibb
John Manthei, Partner, Latham & Watkins LLP
Jeff Nelligan, Communications for the Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Amy Norris, Chief Counsel, Clif Bar & Co.
Jeannie Perron, Partner, Covington & Burling LLP
Cassie Scherer, Principal Legal Counsel, Medtronic
William Schultz, Partner, Zuckerman Spaeder LLP
Julie Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Michael Werner, Partner, Holland & Knight LLP
Continuing Legal Education (CLE)
FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.
10 credits for Ohio
10 credits for Pennsylvania
10 credits for Virginia
Location and Overnight Accommodations
Conference Location
Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue NW
Washington, DC 20004
Business attire is suggested and some meeting rooms may have cooler temperatures.
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.
Overnight Accommodations
A block of rooms has been reserved at the JW Marriott for conference attendees. Reservations can be made online. The group rate is $319/night. Reservations must be received by April 15, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.