From products to consumers to regulation and new media—we’re gathering industry practitioners to take a deep dive on the opportunities and challenges of product advertising. This annual conference will teach you how to communicate your value without overstepping legal and regulatory boundaries.
FDA staff, medical technology company leaders, legal experts and public affairs professionals will lead discussions.
Agenda Topics Include:
- Overview of the Regulation of Medical Device Advertising and Promotion
- CDRH Office of Compliance and Medical Device Advertising
- FTC's Authority Applied to the Regulation of Medical Devices
- An Overview of Recent FDA Guidances and Panel Discussion
- Working with Health Care Professionals
- Mock Promotional Review Group Discussion
- Labeling: General vs. Specific
- Regulatory and Legal Considerations and Criteria when using Social Media
- Enforcement and Compliance
- Global Review Considerations
Presentation slides will be sent after the conclusion of the workshop to attendees.
Speakers include the following:
- Toni Stifano, Division of Premarket and Labeling Compliance, Office of Compliance, CDRH, FDA
- Kendra Jones, Division of Premarket and Labeling Compliance, Office of Compliance, CDRH, FDA
- Marlene Tandy, Assistant General Counsel, Johnson & Johnson
- David Bloch, Principal Legal Counsel, Medtronic
- Nina Sherak, Regulatory Affairs Labeling and Ad/Promo, Medical Products Division, W.L. Gore & Associates
- Tony Blank, Cofounder and Senior Advisor, Barton & Blank
- Monaya Krause, Senior Legal Director, Medtronic
- John Kelly, Bass, Berry, & Sims
- Nancy Stade, Partner, Sidley Austin
- Rebecca Wood, Partner, Sidley Austin
- Joanne Hawana, Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo
- Katherine Norris, Director, Berkeley Research Group
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Cancellation and Refund Policy
All cancellations must be received via email to Sophearay Smith at email@example.com. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact Sophearay Smith at firstname.lastname@example.org with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.