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.

 

Who should attend?

Pharmaceutical and Medical Technology Manufacturers interested in learning about recent changes & implications, and in particular those, working in Compliance, Legal, Finance, Regulatory & Operations.

Agenda

Lawyers from the US and EU (Gardner Law/Fieldfisher) 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

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Speakers:

Ned Mumtaz

Ned Mumtaz has over 25 years of experience in the pharmaceutical industry. He has worked as Director for Wyeth Pharmaceuticals, Schering Plough, Eisai, and Otsuka. Additionally, he has also been a consultant and an advisor for over 50 drug, biologics and device manufacturers..

Mark Gardner

Mark Gardner has provided regulatory counsel to 500+ FDA-regulated companies from around the world. He uses his 20+ years of experience in the health care industry to counsel and train clients on compliance, product approvals, Sunshine Reporting, quality and regulatory matters, and privacy.

Dr. Cord Willhoeft

Dr. Cord Willhoeft is a Life Sciences Partner from Fieldfisher who advises medical device manufacturers and pharmaceutical companies on matters of reimbursement eligibility, regulatory market access and healthcare compliance.

Amanda Johnston

Amanda Johnston specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. She has worked on 50+ FDA submissions.