AUTM Business Development Course: Medical Devices – Clinical and Regulatory Phase

Chicago, IL

Chicago Marriott O'Hare

Robert Wanerman, Member of the Firm, presents "Clinical and Regulatory Phase" as part of the AUTM Business Development Course: Medical Devices.

Bringing a new medical device to market in the U.S. involves multiple regulatory layers. Navigating the multiple approvals that are necessary to successfully commercialize a new device can be an expensive and time-consuming endeavor. This session will focus on those regulatory processes, with the goal of providing a better understanding of the regulators, what regulators expect from manufacturers and how to develop an effective strategy for an individual product. 

The session will address coverage, coding and reimbursement systems, with an emphasis on the following: 

  • Designing and implementing clinical trials to generate data for use by both the Food and Drug Administration (FDA) and payers; 
  • Compliance issues related to clinical trials, including Institutional Review Board (IRB) requirements, conflict of interest issues and fraud and abuse risks; 
  • Reporting obligations under U.S. laws; and 
  • An overview of European Union reimbursement

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