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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

Agenda 
(PDF version)

subject to change 

Thursday, May 3

7:30–8:30 AM | Registration and Continental Breakfast

Amy Comstock Rick, President & CEO, FDLI

Scott Gottlieb, Commissioner of Food and Drugs, FDA
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC, and Chair, FDLI Board of Directors

During this session, speakers will provide an analysis of and update on activities implementing key regulatory initiatives that have come out of FDA, as well as discuss prominent legislation affecting FDA regulation.

Moderated by Amy Comstock Rick, President and CEO, FDLI

10:15–10:45 AM | Coffee and Networking Break

  • Evolving Regulatory Pathways for Medical Devices
  • Regulatory Implications and Practical Challenges of Real World Evidence and Real World Data
  • Regulation of Cell-Based Meat and Other Modified Foods
  • Key Trends and Questions in FSMA Inspections and Compliance of Animal Food
  • Effects of FDA Enforcement on the Tobacco Industry and Consumers

11:30–11:45 AM | Transition

  • The Evolving Regulatory Landscape for Orphan Drugs
  • Biosimilars: New Developments and Updates
  • Medical Device Innovations: Welcome to the Future
  • FSMA Inspections and Compliance for Human Food: Key Trends and Questions
  • Trends in Animal Food Litigation
  • A Smoke-Free World: Evolving Technologies and Policies

Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, FDA

2:00–2:15 PM | Transition

Center for Drug Evaluation and Research (CDER)
Janet Woodcock, Director, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA

Center for Biologics Evaluation and Research (CBER)
Peter W. Marks, Director, Center for Biologics Evaluation and Research, Office of Medical Products and Tobacco, FDA  

Center for Devices and Radiological Health (CDRH)
Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, Office of Medical Products and Tobacco, FDA

Center for Food Safety and Applied Nutrition (CFSAN)
Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, Office of Foods and Veterinary Medicine, FDA

Center for Tobacco Products (CTP)         
Mitchell R. Zeller, Director, Center for Tobacco Products, Office of Medical Products and Tobacco, FDA

Center for Veterinary Medicine (CVM)
Steven M. Solomon, Director, Center for Veterinary Medicine, Office of Foods and Veterinary Medicine, FDA

3:30–4:00 PM | Coffee and Networking Break

  • Generic Drug Initiatives: FDARA, GDUFA II, and Administrative Proposals
  • Regenerative Medicine and the Changing Regulatory Landscape
  • Digital Health Developments and Changing Regulatory Approaches
  • Current Nutrition Facts Labeling Challenges
  • Risk-Based Approval of Tobacco Products

4:45–5:00 PM | Transition

Friday, May 4

7:30–8:15 AM | Breakfast

As manufacturing, sales and product development become more global in nature, there is a growing impact of increasing government agency coordination and cooperation. This session will focus on international cooperation efforts, including FDA’s inspection recognition agreements as well as coordinated actions on imported products.

10:00–11:00 AM | Coffee and Networking Break

  • OTC Drug Monograph Reform
  • From Approval to Coverage – FDA and CMS Jurisdictional Lines
  • EU Medical Device Regulation: Implementation and Compliance
  • Cannabis: FDA’s Role in Regulation
  • Advertising and Marketing in a Mobile World
  • Comprehensive Approach to Nicotine: Misperceptions, Regulations, and Science

11:15–11:30 AM | Transition

  • FDA’s New Approach to Drug and Device Inspections
  • Emerging Issues for Drug Compounders
  • Food and Dietary Supplement Hot Topics
  • Tobacco Prohibition v. Active Harm Reduction Policies

12:15–12:30 PM | Transition

Facilitated Table Topic Discussions
Led by a FDLI-member expert, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the 30+ topics or enjoy open-seating during lunch.

1:15–1:30 PM | Transition

First Amendment issues continue to be prominent in all areas of FDA-regulated industry, including in scientific exchange, product promotion, and as a defense to lawsuits. This panel will discuss FDA and industry perspectives on First Amendment issues and the regulatory landscape in wake of recent cases and FDA guidance and statements.

Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2017, and a look at cases to keep an eye on in 2018. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2017, and Cases to Watch, 2018

3:45 PM | Conference Adjournment

Register by March 22 and SAVE

Industry & Firms

$1,299
  • +$400 for nonmembers
  • +$100 after 3/22/18

Non-Profit

$899
  • +$100 for nonmembers
  • +$100 after 3/22/18

Government

$899
  • +$100 for nonmembers
  • +$100 after 3/22/18

Academic

$899
  • +$100 for nonmembers
  • +$100 after 3/22/18

Student

$299
  • +100 for nonmembers
  • full-time students only
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Do You Qualify for a Complimentary or Discounted Registration?

Member manufacturers, suppliers and distributors with more than $1 billion in sales as well as member law firms get one complimentary registration as part of their annual membership dues.

Member manufacturers, suppliers and distributors with less than $1 billion in sales get one registration at 50% off as part of their annual membership dues.

For more information, please contact us.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

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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.

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 Thursday, March 22, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

2018-02-15T16:28:16+00:00