The annual Enforcement, Litigation, and Compliance Conference brings leading regulators, attorneys, litigators, academics, and consultants together 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. 

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 directly from FDA’s Center Compliance Directors on top issues, priorities, and goals for 2018

Diamond Sponsor

Diamond Sponsor

Gold Sponsor

Silver Sponsor

Silver Sponsor

Silver Sponsor

Bronze Sponsor

Bronze Sponsor

Call for Proposals

What enforcement and compliance concerns are keeping you up at night? We invite industry stakeholders to submit a session topic that you would like to see addressed during the conference. Topics can cover the drug, medical device, food, dietary supplement, or tobacco industries.

Deadline for submissions is Tuesday, August 15.

To submit a topic, please email the following information to Laura Brown, Acting Director, Educational Programs:

  • Title of topic
  • Explanation of topic and relevant details
  • Audience and audience level (e.g., is this a plenary or breakout; geared toward the drug sector; an advanced topic)
  • Is this topic geared toward a specific regulated sector, or geared toward a wide audience?

Your time and input is appreciated. Speaking opportunities are reserved for FDLI members and submission of a topic does not guarantee a speaking opportunity. If your session topic is selected, we may contact you for more information.

Register by October 12 and SAVE!

Industry & Firms

$1,099
  • +$100 for nonmembers
  • +$100 after 10/12/2017
  • +$100 after 11/9/2017

Non-Profit

$799
  • +$100 for nonmembers
  • +$100 after 10/12/2017
  • +$100 after 11/9/2017

Government

$799
  • +$100 for nonmembers
  • +$100 after 10/12/2017
  • +$100 after 11/9/2017

Academic

$799
  • +$100 for nonmembers
  • +$100 after 10/12/2017
  • +$100 after 11/9/2017

Student

$99
  • +$100 for nonmembers
  • +must provide transcripts
  • +must be full-time student

Agenda

Preliminary Agenda will be Announced in September. If you would like to be notified, please let us know.

Planning Committee

Committee Chair

Cathy Burgess, Partner, Alston & Bird LLP

Committee Members

Deborah M. Autor, SVP/Head of Strategic Global Quality & Regulatory Policy, Mylan Pharmaceuticals, Inc.
David J. Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
John C. Garvey, Principal / Chief Executive Officer, Compliance Architects LLC
George M. Karavetsos, Partner, DLA Piper LLP
Peter J. Leininger, Counsel, King & Spalding LLP
Bob Rhoades, Managing Partner, Validant
Marta L. Villarraga, Principal, Exponent, Inc.
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Jessica Zeller, ORA Ombudsman, FDA

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.

Location and Overnight Accommodations

Location

Capital Hilton
1001 16th St NW
Washington, DC 20036

Overnight Accommodations

Rooms are available at a discounted rate of $269 a night through November 14 at the Capital Hilton Hotel.

Driving, Parking, and Public Transportation

Capital Hilton Hotel is a short walk from the McPherson Square and Farragut North Metro stations. Valet parking is available for $59 each day. Parking garages are also available nearby.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.