Huron Webinar: Fair Market Value and Compliance within the Clinical Setting
In this webinar, Huron explores Fair Market Value and Compliance within the Clinical Setting for Compliance, Legal, Medical Affairs and Clinical Budeting professionals.
Key questions discussed:
- What is Fair Market Value?
- Why is determining Fair Market Value important for Clinical Research?
- What key laws and regulations apply?
- What are the different tools and ways in which manufacturers are assessing Fair Market Value?
- What are the key items of consideration and risk areas in determining Fair Market Value?
- What is the healthcare provider perspective in determining Fair Market Value?
- What challenges do manufacturers experience in assessing Fair Market Value?
- Why is Fair Market Value emerging as an issue of concern?
- How can compliance and legal professionals best work with Medical Affairs and Clinical Budgeting to manage compliance and legal risk?
Why is now the time to watch this webinar?
The process of ensuring payments for clinical research represent Fair Market Value is not well established in many companies, yet manufacturers will spend an estimated $144 billion on clinical research in 2016 with much of this spend subject to transparency regulations requiring disclosure. This spend combined with an increasing emphasis by regulatory authorities on Fair Market Value as a tool to ensure compliance and identify transgressions, makes it clear that assessing, approving and documenting Fair Market Value within the clinical research setting should not be ignored.
In addition to regulatory concerns, manufacturers and research providers have a shared and keen interest in refining and expediting the review, approval and launch of clinical research projects. Establishing a process for setting Fair Market Value ensures that the focus is on the right variables within project budgets, aligns all parties on the key aspects of the budget, and provides the basis for a well-documented exceptions process. Ensuring each dollar of spend represents Fair Market Value can literally save manufacturers a significant amount of time and money.
Mark DeWyngaert, PhD, MBA
John Moose, MBA, ABV, CPA
Nirmala Thevathasan, MPHWatch Webinar
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