Why Attend?

Agenda
Location & CLE

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 use emerging technologies in promotional contexts, and updated government agency enforcement trends. Apply your knowledge through drug- and device-oriented case studies.

Government Speakers: Representatives from CDER, CDRH, CVM, DOJ, FTC, and OIG will provide the latest information on policy, enforcement, and future initiatives.

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

Keynote Address: Lowell Schiller, Principal Associate Commissioner for Policy, FDA

Last Year’s Attendees at a Glance

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FDA Officials from CBER, CDER, CDRH, CTP, CVM, and OC
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Manufacturing Companies Represented
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Attendees

Call For Proposals

FDLI and the Conference Planning Committee thanks those who participated in the Call for Proposals. 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 July.

Sponsors

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

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Planning Committee

Co-Chairs

Paul J. Savidge, US General Counsel, Spark Therapeutics

Ellen Shumacher, Executive Director, Bristol-Meyers Squibb Company

Committee Members 

Fadwa Almanakly, Bayer Healthcare Pharmaceuticals
Heather Banuelos, King & Spalding LLP
Rebecca Burnett, Framework Solutions
Kellie B. Combs, Ropes & Gray LLP
Virginia Foley, Opus Regulatory, Inc.
Mark Gaydos, Sanofi
Bryant M. Godfrey, Arnold & Porter LLP
Kelly F. Goldberg, PhRMA
Chris Hughes, Sr., Boston Scientific Corporation
Tim Kreidler, Dermira, Inc.
Daniel McHugh, Celgene Corporation
Cynthia L. Meyer, Kleinfeld, Kaplan & Becker, LLP
Lauren Miller, Otsuka America Pharmaceutical, Inc.
Wayne Pines, APCO Worldwide
Lucy Rose, Lucy Rose & Associates, LLC
Dolores M. Shank-Samiec, Merck & Co., Inc.