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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 two-day event 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-profits, patient and consumer advocates, consulting organizations, and academia.

Conference Highlights:

  • Hear FDA’s 2019 strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency
  • Join more than 900 high-level 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

Call For Proposals

FDLI and the 2019 Annual Conference Planning Committee thank those who participated in the Call for Proposals this past fall. The input received from industry stakeholders helps us plan a timely program. If you submitted a proposal, you will be notified of the status of your proposal in February.

Register by March 21 and SAVE

Industry & Firms

$1,499
  • +$500 for nonmembers
  • +$100 after 03/21/19

Non-Profit

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Government

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Academic

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Student

$299
  • student registration
  • transcripts required
Register Now

  
Does Your FDLI Membership Qualify You 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. To take advantage of these opportunities, 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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Agenda

subject to change

Thursday, May 2

8:00–9:15 AM
Registration and Continental Breakfast

9:15–9:30 AM  
Welcome
Amy Comstock Rick, President & CEO, FDLI

9:30–10:00 AM    
FDA Keynote Address
Scott Gottlieb, Commissioner of Food and Drugs, FDA (Invited)
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom, and Chair, FDLI Board of Directors

10:00–11:00 AM
Policies and Politics – Opportunities and Challenges Facing the FDA
This panel features an interactive, forward-looking discussion on the bigger picture direction and anticipated short- and long-term issues facing FDA and the food and drug communities.

11:00–11:30 AM
Coffee and Networking Break

11:30—12:30 PM  
Breakout Sessions

  • Incentivizing Generic and Biosimilar Competition
  • Evolving 510(k) Program and De Novo Process
  • Innovative Medical Product Technologies, Novel Products, and FDA Regulation
  • Animal Drugs and Antimicrobial Resistance
  • Federal Oversight of Food Biotechnology
  • Modified Risk Tobacco Product Applications: Status Update

12:30–1:30 PM   
Networking Luncheon and FDLI Awards Presentation

1:30–2:00 PM 
Luncheon Speaker

2:00–2:10 PM 
Transition

2:10–3:25 PM      
Breakout Sessions: FDA Center Directors

  • Center for Drug Evaluation and Research (CDER)
    Janet Woodcock, Director, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA (Invited)
  • Center for Biologics Evaluation and Research (CBER)
    Peter W. Marks, Director, Center for Biologics Evaluation and Research, Office of Medical Products and Tobacco, FDA  (Invited)
  • 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 (Invited)
  • Center for Veterinary Medicine (CVM)
    Steven M. Solomon, Director, Center for Veterinary Medicine, Office of Foods and Veterinary Medicine, FDA (Invited)

3:25–3:50 PM  
Coffee and Networking Break

3:50–4:50 PM     
Breakout Sessions

  • Clinical Trials and the Use of Real-World Data in Medical Product Development
  • FDA’s Software Precertification Program
  • New Advances and Updates in the Biologics and Biosimilars Landscape
  • Updates in Animal Food and Feed: State Changes, GRAS, and FSMA
  • Food and Dietary Supplement Class Action Litigation: Developments and Strategies
  • What’s New in the World of Combustible Tobacco Products

4:50–5:00 PM      
Transition

5:00–5:30 PM                   
Speaker:
Stacy Cline Amin, Chief Counsel, FDA (Invited)

5:30–7:00 PM
Networking Reception

Friday, May 3

8:00—8:45 AM      
Breakfast

8:45—9:00 AM 
FDLI Welcome and Service to FDLI Award

9:00—9:20 AM   
Dr. Harvey Wiley Lecture and FDAAA Award

9:20–10:20 AM   
Globalization, Emerging Markets, and International Trends

10:20–10:40 AM         
Coffee and Networking Break

10:40–11:30 AM             
Breakout Sessions

  • Understanding DEA Regulations and FDA Interactions: A Case Study on Opioids
  • Machine Learning, AI, and Digital Health
  • Precision Medicine, Next-Generation Sequencing, and Diagnostics
  • Updates in International Food Regulation and Trade: Foreign Supplier Verification Program, Efforts in Harmonization, EU Regulations, and the United States-Mexico-Canada Agreement
  • Electronic Nicotine Delivery Systems Part I: Regulation to Prevent Youth Initiation and Use
  • Focus on Investigations: Government Trends and Best Practices for Internal Investigations

11:30–11:40 AM      
Transition

11:40 AM–12:30 PM     
Breakout Sessions

  • Orphan Drug and Rare Disease Developments
  • Issues in Drug Quality and Manufacturing: ConOps, Quality Metrics, and Outsourcing
  • Drug and Device Privacy and Cybersecurity Considerations
  • “Sugar” and “Natural” Food Label Claims and Litigation – What’s Next?
  • Electronic Nicotine Delivery Systems Part II: Adult Smoker Cessation and Harm Reduction
  • Marijuana, CBD, and Hemp: Understanding the Current Regulatory Landscape and How it Might Change

12:30–1:40 PM         
Luncheon

  • Facilitated Table Topic Discussions
    Led by FDLI-member experts, 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.

1:40–1:45 PM      
Transition

1:45–2:30 PM  
Breakout Sessions

  • Regenerative Medicine, Gene Therapies, and FDA Regulation
  • Patient Input in Medical Product Development
  • Issues and Updates in Combination Products Regulation
  • International Medical Device Regulation and Harmonization
  • An In-Depth Look at GRAS and Food Ingredient Regulation
  • Tobacco Litigation Update

2:30–2:45 PM        
Coffee and Networking Break

2:45–4:00 PM     
Top Cases in Food and Drug Law
Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2018, and a look at cases to keep an eye on in 2019. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2018, and Cases to Watch, 2019

4:00 PM    
Conference Adjournment

Planning Committee

Co-Chairs

Amy Norris
Chief Counsel, Clif Bar & Company

William Schultz
Partner, Zuckerman Spaeder LLP

Committee Members

Azim Chowdhury, Partner, Keller and Heckman LLP
Dean R. Cirotta, President & COO, EAS Consulting Group, LLC
James N. Czaban, Partner, DLA Piper LLP
Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation,
University of Maryland Carey School of Law
Brenda Huneycutt, Director, Regulatory Innovation, FasterCures
Madeleine M. McDonough, Partner and Chair, Shook, Hardy & Bacon LLP
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization
Adora Ndu, Executive Director, Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical Inc.
Vernessa Pollard, Partner, McDermott Will & Emery
Stuart Pape, Shareholder, Polsinelli PC
Cassie Scherer, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Julia (Julie) Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Michael Werner, Partner, Holland & Knight LLP
José Alberto Campos Vargas, Partner, Sánchez Devanny

 

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

JW Marriott
1331 Pennsylvania Avenue NW
Washington, DC 20004

A discounted block of rooms has been reserved at the JW Marriott for conference attendees.  The JW Marriott is a short walk from the Ronald Reagan Building.  Reservations can be made online and must be completed by Tuesday, April 9 to receive the $329.00 rate.  After this date, rooms are subject to prevailing rates and availability.  If you need further assistance contact us at [email protected].

2019-02-20T12:12:57+00:00