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The annual Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This conference offers an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies. 

Keynote Speakers:

  • Scott Gottlieb, Commissioner of Food and Drugs, FDA
  • James Burnham, Deputy Assistant Attorney General, Consumer Protection Branch, US Department of Justice
  • Stacy Cline Amin, Chief Counsel, FDA (Invited)

Attendees Will:

  • Explore the latest trends behind enforcement actions in food, drugs, biologics, medical devices, and tobacco
  • Gain practical tips and best practices for responding to enforcement action by FDA or other government agencies
  • Learn how to comply with new and upcoming FDA rules and regulations
  • Hear about top issues, priorities, and goals for 2019 directly from FDA’s Center Compliance Directors, including:
    • Donald Ashley, Director, Office of Compliance, CDER
    • William Maisel, Director, Office of Device Evaluation and Acting Director, Office of Compliance, CDRH
    • Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, CBER
    • William Correll, Director, Office of Compliance, CFSAN
    • Ann Simoneau, Director, Office of Compliance and Enforcement, CTP
    • Eric Nelson, Director, Office of Surveillance and Compliance, CVM

Register by October 18 and SAVE

Industry & Firms

$1099
  • +$400 for non-members
  • +$100 after 10/18/2018
  • +$100 after 11/15/2018

Non-Profit

$799
  • +$100 for non-members
  • +$100 after 10/18/2018
  • +$100 after 11/15/2018

Government

$799
  • +$100 for non-members
  • +$100 after 10/18/2018
  • +$100 after 11/15/2018

Academic

$799
  • +$100 for non-members
  • +$100 after 10/18/2018
  • +$100 after 11/15/2018

Student

$99
  • student registration
  • full-time students only
  • transcripts required
Register Now

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.

Call for Proposals

FDLI and the Conference Planning Committee thanks those who participated in the Call for Proposals this summer. 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 September.

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Agenda

Subject to Change

Wednesday, December 12

8:00–8:45 AM                
Registration and Continental Breakfast

8:45–9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
George M. Karavetsos, Partner, DLA Piper LLP and Chair, Enforcement, Litigation, and Compliance Conference

9:00–9:30 AM                 
Keynote Address
Scott Gottlieb, Commissioner of Food and Drugs, FDA

9:30–10:40 AM              
Compliance Central with FDA Center Compliance Directors: Part I
This two-part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2019. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and what to expect when you don’t follow FDA regulations.

Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
William Maisel, Director, Office of Device Evaluation and Acting Director, Office of Compliance, Center for Devices and Radiological Health, FDA
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA

10:40–11:00 AM            
Coffee and Networking Break                                            

11:00–12:00 PM            
Compliance Central with FDA Center Compliance Directors: Part II

Eric M. Nelson, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
William Correll, Director, Office of Compliance, Center for Food Safety and Nutrition, FDA
Ann Simoneau, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA

12:00–1:15 PM            
Luncheon Address
Stacy Cline Amin
, Chief Counsel, FDA (Invited)

1:15–2:10 PM                 
Concurrent Sessions: 

  • Delaying, Denying, Limiting, or Refusing Inspections: How to Prepare to Say Yes and Effectively Say No
    Daniel Jarcho, Partner, Alston & Bird LLP
    William McConagha, Partner, Sidley Austin LLP

  • Looking Forward: OTC Drug Compliance
    David Horowitz, Partner, Hogan Lovells US LLP

  • Consumer Fraud Cases on Food and Drugs
    John F. Johnson
    , Senior Associate Attorney, FDAImports.com LLC / Benjamin L. England & Associates LLC

 2:15–3:10 PM                 
Concurrent Breakout Sessions:

  • The Benefits and Risks of Internal Audits and Investigations
    Frances M. Zipp
    , President & CEO, Lachman Consultant Services, Inc.
    Moderated by Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP

  • Ensuring Manufacturing Compliance with Cell and Gene Therapies
    Jonathan Levitt, Co-Founding Partner; Attorney, Frier & Levitt

  • Emerging Trends in State and Federal Opioid Investigations and Prosecutions
    Moderated by Kalah Auchincloss, Senior Vice President, Regulatory Compliance, and Deputy General Counsel, Greenleaf Health, Inc.

3:10–3:30 PM                 
Coffee and Networking Break

3:30–4:30 PM                 
Imports, Import Alerts, and Harmonization: Enforcement Trends and Updates
Kimberly Trautman
, Executive Vice President, Medical Device International Services, NSF International

4:30–5:30 PM
Top FDA Enforcement Cases in 2018
Anne Walsh
, Director, Hyman, Phelps & McNamara, PC

5:30–7:30 PM                 
FDLI 2018 Annual Holiday Reception

 

 

Thursday, December 13

8:30–8:55 AM                
Registration and Continental Breakfast

8:55–9:00 AM                 
FDLI Welcome and Remarks
Laura Brown, Director, Educational Programs, FDLI

9:00–9:30 AM                
Keynote Address
James Burnham, Deputy Assistant Attorney General, Consumer Protection Branch, US Department of Justice

9:30–10:30 AM              
What are the DOJ Enforcement Trends Regarding FDA-Regulated Companies?
Brandon Moss
, Associate, Wiley Rein LLP
Michele Sartori, Partner, Hogan Lovells US LLP

10:30–10:45 AM            
Coffee and Networking Break

10:45–11:45 AM            
Concurrent Breakout Sessions:

  • Responding to Data Integrity Issues and Best Practices 
    Cynthia Schnedar, Executive Vice President, Compliance and Regulatory Affairs, Greenleaf Health, Inc.
    Cathy Burgess, Partner, Alston & Bird LLP
    Douglas Farquhar, Director, Hyman, Phelps & McNamara, PC
    Moderated by Jack Garvey, Principal/Chief Executive Officer, Compliance Architects LLC

  • REMS as an Enforcement Tool
    Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors

  • Tobacco Enforcement Challenges and Recent Actions
    Stacy Ehrich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors

11:50–12:50 PM              
Concurrent Breakout Sessions:

  • Managing a Recall: Preparing for Regulatory and Legal Implications
    Victoria Calhoon, Attorney, Faegre Baker Daniels LLP
  • False Claims Act Enforcement: Reimbursement Activities and Trends
    Hannah Bornstein, Partner, Nixon Peabody LLP
    Abe Gitterman, Associate, Arnold & Porter LLP

1:00–2:15 PM                 
Luncheon Address: Sixth Annual Eric M. Blumberg Memorial Lecture

2:15 PM                           
Conference Adjournment

 

2018 Planning Committee

Deborah Autor, Mylan
Jack Garvey, Compliance Architects LLC
George Karavetsos, DLA Piper
Mark Mansour, Foley Hoag LLP
Matthew Newcomer, Post & Schell PC
Cynthia Schnedar, Greenleaf Health LLC
Howard Sklamberg, Akin Gump
Kim Trautman, NSF Health Sciences
Anne Walsh, Hyman Phelps & McNamara PC
Jessica Zeller, FDA/ORA

Continuing Legal Education

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.

Conference Location

JW Marriott
1331 Pennsylvania Ave NW
Washington, DC 20004

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 $259/night. Reservations must be received by November 12, 2018 to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

Driving, Parking, and Public Transportation

The JW Marriott is a short walk from Metro Center.   Valet parking is available for $59 each day. Parking garages are also available nearby.

2018-10-17T09:46:24+00:00