Are you up-to-date with the latest US and EU transparency reporting and marketing requirements for drug and device makers?

June 16, 2021 @ 11:00 am CST

Join us for a complimentary webinar tailored to pharmaceutical and medical technology manufacturers, followed by Live Q&A.


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Learn about updated and existing Transparency Regulations in the US and EU, recent DOJ Sunshine Act related enforcement actions, and the impact of the OIG’s Special Fraud Alert on Speaker Programs.

 

Date: Wednesday, June 16th, 2021, 11–12:30pm CST, 6–7:30pm CET.

Attorneys from the US and EU will cover:

  • US Federal Physician Payments Sunshine Act, a.k.a., Open Payments
  • Updates to the Sunshine Act—with the expansion to cover certain mid-level prescribers, changes to nature of payment types, etc.
  • EU sunshine laws and codes, including effect of GDPR on reporting
  • US state and local sunshine and marketing laws and enforcement (CA, CO, CT, DC, NV, MA, MN, VT, Chicago, Miami-Dade County, among others)
  • Recent case law, including the recent DOJ Sunshine Act-related settlements involving: Medicrea, Medtronic, Medical Designs LLC and Sicage LLC, which included a practicing physician
  • Impact of the OIG’s Special Fraud Alert on Speaker Programs in light of federal, state and local transparency and marketing requirements
  • Overview of global transparency requirements outside of the US/EU

Global Compliance Reporting Professional (Vector Health) will cover:

  • Best practices for manufacturers to ensure accurate payment tracking and reporting amidst recent law changes
  • Use of analytics and monitoring to understand and safeguard spend
  • Practical approaches to meet the OIG’s Special Fraud Alert on Speaker Programs

Speakers:

Mark Gardner   Amanda Johnston  


Sponsored by:

 


Attendees include Pharmaceutical and Medical Technology Manufacturers interested in learning about recent changes & implications, and in particular, those working in Compliance, Legal, Finance, Regulatory & Operations. CLE credits – Application pending in various jurisdictions. Please contact Tracy at terickson@gardner.law with any questions.