Hot Topics * Connect and Interact * Expert Presenters

Join hundreds of your colleagues from across the food and drug law community at this must-attend annual event to hear directly from leading regulators, both within and outside FDA, explore different viewpoints, shape policy, and advance understanding.

  • Hear FDA’s 2017 strategic priorities directly from the Acting Commissioner, Chief Counsel, and leadership of FDA’s product Centers;
  • Informative and thought-provoking plenary sessions;
  • More than 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and economic issues;
  • Learn from more than 100 well-known leaders in the federal government, industry, private bar, patient and consumer advocacy groups, consulting organizations, and academia; and
  • A variety of opportunities to learn and network in both large and small groups.

Sessions Include

  • Policies and Politics – Opportunities and Challenges for a New Administration
  • 21st Century Cures Act: FDA Provisions and Implications
  • Top 10 Cases in Food and Drug Law
  • Networking Lunch with Facilitated Table Topic Discussions

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: FDLI Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, MD, Acting Commissioner, Food and Drug Administration (FDA) (invited)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

  • Data Collaboration and Clinical Data Disclosure in the Pharmaceutical Industry
  • Laboratory Developed Tests, FDA Oversight, and Current Legislation
  • Key Regulatory Issues in Biosimilars
  • “New” Food Ingredients: US and EU Requirements and Strategic Considerations
  • Animal Drug Compounding
  • Tobacco Product Standards in the US and EU

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

  • Communicating Emerging Drug Therapies Prior to FDA Approval
  • Digital Health Technologies: A New FDA Regulatory Paradigm
  • Regulatory Challenges of Biologics Across the Globe
  • Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
  • Patient-Centric Perspectives: Models for Patient Engagement
  • Tobacco Industry and Deeming: One Year Later

12:30–2:00 PM: Luncheon

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

  • Center for Drug Evaluation and Research (CDER)
    Richard A. Moscicki, MD, Deputy Director for Science Operations, CDER, Office of Medical Products and Tobacco, FDA
  • Center for Devices and Radiological Health (CDRH)
    Jeffrey Shuren, MD, Director, CDRH, Office of Medical Products and Tobacco, FDA
  • Center for Biologics Evaluation and Research (CBER)
    Peter W. Marks, MD, PhD, Director, CBER, Office of Medical Products and Tobacco, FDA
  • Center for Food Safety and Applied Nutrition (CFSAN)
    Susan T. Mayne, PhD, Director, CFSAN, Office of Foods and Veterinary Medicine, FDA
  • Center for Veterinary Medicine (CVM)
    Steven M. Solomon, DVM, MPH, Director, CVM, Office of Foods and Veterinary Medicine, FDA (invited)
  • Center for Tobacco Products (CTP)
    Mitchell R. Zeller, Director, CTP, Office of Medical Products and Tobacco, FDA

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

  • Pharmacy Adherence and Discount Programs
  • FDA’s New Oncology Center of Excellence
  • Issues in Biologics Compliance and Enforcement
  • What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
  • FDA vs. USDA Regulation of Veterinary Medicine
  • Tobacco and the Move to Non-Combustible Products

4:45–5:00 PM: Transition
5:00–5:30 PM: Elizabeth H. Dickinson, Chief Counsel, FDA (invited)
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
8:30–9:15 AM: FDLI Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Keynote Address
9:15–9:30 AM: FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA (invited)

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

  • Challenges and Opportunities in Combination Medical Product Regulation
  • FDA’s Implementation of the 21st Century Cures Act
  • Regulation of Cannabis in FDA-Regulated Products
  • Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
  • CTP’s Compliance and Enforcement Initiatives Post-Deeming

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

  • User Fee Program Reauthorization: Policy Issues and Current Bills
  • Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
  • Defending Your Product: Crisis Management, Recalls, and Strategy

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: FDLI Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, MD, Acting Commissioner, Food and Drug Administration (FDA) (invited)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

  • “New” Food Ingredients: US and EU Requirements and Strategic Considerations

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

  • Food and Dietary Supplement Class Action Litigation in a World of Less Regulation

12:30–2:00 PM: Luncheon

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

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

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

  • What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement

4:45–5:00 PM: Transition
5:00–5:30 PM: Elizabeth H. Dickinson, Chief Counsel, FDA (invited)
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
8:30–9:15 AM: FDLI Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Keynote Address
9:15–9:30 AM: FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA (invited)

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

  • Regulation of Cannabis in FDA-Regulated Products
  • Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

  • Defending Your Product: Crisis Management, Recalls, and Strategy

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: FDLI Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, MD, Acting Commissioner, Food and Drug Administration (FDA) (invited)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

  • Data Collaboration and Clinical Data Disclosure in the Pharmaceutical Industry
  • Laboratory Developed Tests, FDA Oversight, and Current Legislation
  • Key Regulatory Issues in Biosimilars
  • Animal Drug Compounding

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

  • Communicating Emerging Drug Therapies Prior to FDA Approval
  • Digital Health Technologies: A New FDA Regulatory Paradigm
  • Regulatory Challenges of Biologics Across the Globe
  • Patient-Centric Perspectives: Models for Patient Engagement

12:30–2:00 PM: Luncheon

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

  • Center for Drug Evaluation and Research (CDER)
    Richard A. Moscicki, MD, Deputy Director for Science Operations, CDER, Office of Medical Products and Tobacco, FDA
  • Center for Devices and Radiological Health (CDRH)
    Jeffrey Shuren, MD, Director, CDRH, Office of Medical Products and Tobacco, FDA
  • Center for Biologics Evaluation and Research (CBER)
    Peter W. Marks, MD, PhD, Director, CBER, Office of Medical Products and Tobacco, FDA
  • Center for Veterinary Medicine (CVM)
  • Steven M. Solomon, DVM, MPH, Director, CVM, Office of Foods and Veterinary Medicine, FDA (invited)

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

  • Pharmacy Adherence and Discount Programs
  • FDA’s New Oncology Center of Excellence
  • Issues in Biologics Compliance and Enforcement
  • FDA vs. USDA Regulation of Veterinary Medicine

4:45–5:00 PM: Transition
5:00–5:30 PM: Elizabeth H. Dickinson, Chief Counsel, FDA (invited)
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
8:30–9:15 AM: FDLI Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Keynote Address
9:15–9:30 AM: FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA (invited)

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

  • Challenges and Opportunities in Combination Medical Product Regulation
  • FDA’s Implementation of the 21st Century Cures Act
  • Regulation of Cannabis in FDA-Regulated Products
  • Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

  • User Fee Program Reauthorization: Policy Issues and Current Bills
  • Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
  • Defending Your Product: Crisis Management, Recalls, and Strategy

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: FDLI Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, MD, Acting Commissioner, Food and Drug Administration (FDA) (invited)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

  • Tobacco Product Standards in the US and EU

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

  • Tobacco Industry and Deeming: One Year Later

12:30–2:00 PM: Luncheon

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

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

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

  • Tobacco and the Move to Non-Combustible Products

4:45–5:00 PM: Transition
5:00–5:30 PM: Elizabeth H. Dickinson, Chief Counsel, FDA (invited)
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
8:30–9:15 AM: FDLI Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Keynote Address
9:15–9:30 AM: FDA Alumni Association Award Presentation
9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA (invited)

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Supply Chain Management Risks
11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

  • CTP’s Compliance and Enforcement Initiatives Post-Deeming

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

  • Defending Your Product: Crisis Management, Recalls, and Strategy

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law
4:30 PM: Conference Adjournment

Register By March 31 and SAVE!

Industry & Firms

$1,499
  • +$400 for nonmembers
  • +$100 after 3/31/17

Non-Profit

$1,099
  • +$100 for nonmembers
  • +$100 after 3/31/2017

Government

$1,099
  • +$100 for nonmembers
  • +$100 after 3/31/2017

Academic

$1,099
  • +$100 for nonmembers
  • +$100 after 3/31/2017

Student

$299
  • +$100 for nonmembers
  • +must provide transcripts

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.
  • Organizational members are also eligible for a group registration discount. Pay for four attendees and the fifth is complimentary.

To take advantage of these opportunities, please contact the Membership Department.

For other Annual Conference questions, please contact Customer Service.

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Questions?

Planning Committee

Co-Chairs

Dave Ceryak
Senior Director – Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company

Leslie T. Krasny
Partner, Keller and Heckman LLP

Planning Committee

Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville and American Heart Association
Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.
Neil DiSpirito, Of Counsel, Ballard Spahr LLP
Joy Liu, Vice President, Commercial and Regulatory Legal, Vertex Pharmaceuticals
Jeff Nelligan, Communications for the Deputy Commissioner for Global Regulatory Operations and Policy, FDA
May Nelson, Deputy Director, Office of Regulations, Center for Tobacco Products, Office of Medical Products and Tobacco, FDA
Jeannie Perron, Partner, Covington & Burling, LLP
Kim Tyrrell-Knott, Member of the Firm, Epstein Becker & Green

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.

Call for Proposals

The Planning Committee thanks all who participated in the Call for Proposals that took place this past Fall. The broad input on topics from our members has helped us to put together a tremendous program.

Location and Overnight Accommodations

Conference Location

Ronald Reagan Building and International Trade Center 
1300 Pennsylvania Avenue NW
Washington, DC 20004

Overnight Accommodations

Rooms are available at a discounted rate of $309 a night through April 11, 2017 at the JW Marriott Hotel. After that date, rates and availability may vary.

Make Reservation

Business attire is recommended and some meeting rooms may have cooler temperatures.

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