This must-attend event for medical product industry stakeholders brings together regulatory practitioners, industry experts, and government officials to engage on the latest trends and updates in advertising and promotion through panel discussions and case studies.

Practical Takeaways: Explore the current state of off-label promotion, how to evaluate and use real-world evidence, digital health technologies, OIG compliance trends and significant developments, and operationalizing FDA’s recent guidance documents.

FDA Speakers: Representatives from all four of FDA’s medical product centers will provide the latest information on policy, enforcement, and future initiatives.

Peer Interaction: Network with and learn from legal and regulatory experts.

Highlighted Topics:

  • Utilization of Real-World Evidence
  • Scientific Exchange
  • Digital Health Technologies and Communications
  • Operationalizing FDA’s Recent Guidance Documents
  • OIG Compliance Trends and Significant Developments
  • Submissions of Promotional Materials
  • FDA Enforcement Actions
  • Effectively Responding to FDA Warning Letters
  • Advertising and Promotion Requirements for Biologics and Biosimilars

Gold Sponsor

Gold Sponsor

Gold Sponsor

Gold Sponsor

Silver Sponsor

Silver Sponsor

Silver Sponsor

Bronze Sponsor

Bronze Sponsor

Call for Proposals

The Planning Committee thanks those who participated in the Call for Proposals that took place this spring. The broad input on topics from medical product industry stakeholders helps to ensure a timely and relevant program. Those who submitted a topic will be notified of the status of their proposal by the end of June.

Register by August 17 and SAVE!

Industry & Firms

$1,249
  • +$600 for non-members
  • +200 after 8/17/2017

Non-Profit

$849
  • +$100 for non-members
  • +$50 after 8/17/2017

Government

$849
  • +$100 for non-members
  • +$50 after 8/17/2017

Academic

$849
  • +$100 for non-members
  • +$50 after 8/17/2017

Student

$149
  • +$100 for non-members
  • +must provide transcripts

Are You New to Advertising and Promotion?

Add the half-day training course, Introduction to Advertising and Promotion, to your conference registration to gain a comprehensive overview of the laws and regulations affecting the medical products industries and save $100 on the combined registration fees.

Sponsorship Opportunities

Sponsorship opportunities are available. Please let us know if you would like more information.

Agenda

subject to change

Monday, September 25

At Latham & Watkins LLP
555 11th St NW, Washington, DC 20004

1:00 – 5:00 PM
Introduction to Advertising and Promotion
Add this half-day course to your registration and save $100 on the combined registration fees.

5:30-7:00 PM 
Out-of-Towners Reception

Tuesday, September 26

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

8:45-9:00 AM 
Welcome
Amy Comstock Rick
, President & CEO, Food and Drug Law Institute (FDLI)

9:00-10:00 AM 
FDA’s Advertising and Promotion Initiatives and Recent Guidance Documents
Moderated by FDA

10:00-10:45
Off-Label Regulation, Compliance, and Enforcement under the New Administration

10:45-11:15 AM 
Coffee Networking Break

11:15-12:00 PM 
Breakout Sessions

  • Proactive and Reactive Strategies and Tactical Approaches for Communicating with FDA
  • Enhancing Patient Centricity: Communication and Involvement
  • Advertising and Promotion of Biological Products and Biosimilars

12:00-12:15 PM 
Transition

12:15-1:30 PM 
Luncheon: Keynote Speaker

1:30-1:45 PM 
Transition

1:45-2:45 PM 
Recent FDA Enforcement Actions
Moderated by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide, and Planning Committee Co-Chair

2:45-3:00 PM 
Coffee and Networking Break

3:00–4:00 PM
FDA’s Social Science Research
Moderated by FDA

4:00–5:00 PM
Advertising and Promotional Communications in a Mobile World

5:00–6:30 PM
Networking Reception

Wednesday, September 27

8:30–8:50 AM
Breakfast

8:50–9:00 AM
Welcome
Tirza Lofgreen, Director, Educational Programs, FDLI

9:00–10:00 AM
Decision Making and Risk Assessment in Advertising and Promotion
Moderated by Lucy Rose, President, Lucy Rose & Associates, LLC, and Planning Committee Co-Chair

10:00–11:00 AM
OIG and DOJ Compliance and Enforcement Trends and Developments 

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

11:30–12:15 PM
Breakout Sessions

  • Proactive Communications about Medical Products between Manufacturers and Payors
  • Medical Devices: Operationalizing FDA’s New Guidance Documents
  • Drugs: FDA’s Guidance on Electronic Submissions of Promotional Materials

12:15–12:30 PM
Transition

12:30–1:30 PM
Luncheon and Facilitated Table Topic Discussions
These facilitated, informal discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on an advertising and promotion topic. Attendees have the option to choose from one of the 15+ topics or enjoy open-seating during lunch.

1:30–1:45 PM
Transition

1:45–2:45 PM
Real World Evidence: Data Requirements, Utilization, and Presentation 

2:45–3:45 PM
Scientific Exchange and the First Amendment

3:45 PM
Conference Adjournment

Planning Committee

Co-Chairs

Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide
Lucy Rose, President, Lucy Rose & Associates, LLC

Committee Members

Kaitlin Backfield, Backfield Consulting LLC
Kellie Combs, Partner, Ropes & Gray LLP 
Dale Cooke, Philly Cooke Consulting
Jim Czaban, Chair FDA Practice Group, DLA Piper LLP
Mark Gaydos, Vice President, Global Regulatory Affairs, Sanofi
Matthew Hill, Senior Corporate Counsel, Novo Nordisk Inc.
Colleen Klasmeier, Partner, Sidley Austin LLP 
Michael Labson, Partner, Covington & Burling LLP
Paul Savidge, Senior Regulatory Counsel, Spark Therapeutics, Inc.
Michele Sharp, Sr. Director, Global Regulatory Affairs – US, Eli Lilly and Company
Kristi Wolff, Partner, Kelley Drye & Warren LLP

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

Conference Location

Renaissance Downtown Hotel
999 Ninth St NW
Washington, DC 20001

Overnight Accommodations

Rooms are available at a discounted rate of $319 a night through August 31 at the Renaissance Downtown Hotel. Online registration is required to qualify for the discounted rate.

Reserve Your Room

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.

Driving, Parking, and Public Transportation

Renaissance Downtown Hotel is a short walk from Metro Center and Gallery Place/Chinatown metro stations. Onsite parking fee is $35 a day, valet parking is $45. Parking garages are also available nearby.