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Why Attend?

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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.

Keynote Address: Lauren Silvis, Chief of Staff, Office of the Commissioner, FDA

Practical Takeaways: Explore the current state of off-label promotion, how to evaluate and use real-world evidence, and the increasing challenges of various direct-to-consumer marketing platforms.

FDA Speakers: Representatives from CBER, CDER, CDRH, and CVM will provide the latest information on policy, enforcement, and future initiatives.

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

Highlighted Topics:

  • Real-World Evidence and Real-World Data: Practices for Promotional Use and Avoiding False and Misleading Communications
  • Company Perspectives on Addressing, Interpreting, and Implementing the “Consistent with Label” and “Payor” Guidances
  • Technological Considerations: Metadata, Native Advertising, and New Technologies 
  • Device Promotion and the First Amendment
  • The Do’s and Don’ts of Patient Communications
  • Co-Promotion, Co-Marketing, and Co-Advertising
  • Promotional Compliance and Liability Risks Beyond the FDA
  • Regulatory Challenges of Advertising and Promotion of Medical Devices and IVDs
  • Non-Traditional Venues and Product Promotion: Press Releases, Promotional Booths, DTC Platforms, Influencers, Distributors, and More
  • FDA’s Finalized Guidance Documents – Where Do We Go From Here?
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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

“The amount and quality of info provided was exceptional, answered many questions that I came with, and addressed current hot button issues.”

Attendee Evaluation

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Sponsorship opportunities are available, click here to download the brochure. Please let us know if you would like more information.

Planning Committee

Co-Chairs

Kellie Combs
Partner, Ropes & Gray LLP

Mark Gaydos
Vice President, Global Regulatory Affairs, Sanofi

Committee Members

Dale Cooke, PhillyCooke Consulting
Lisa Dwyer, King & Spalding
Kelly Goldberg, PhRMA
Wayne Pines, APCO Worldwide
Jennifer Romanski, Porzio Bromberg & Newman PC
Lucy Rose, Lucy Rose & Associates LLC
Paul Savidge, Spark Therapeutics Inc.
Ellen Schumacher, Bristol-Myers Squibb Company

 

2018-10-18T16:17:37+00:00