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

Dallas, TX

Hyatt Regency Dallas

Robert Wanerman, Member of the Firm, will give two presentations, "Clinical and Regulatory Phase" and "Legal Issues," as part of the AUTM Business Development Course: Medical Devices.

Mr. Wanerman's "Clinical and Regulatory Phase" presentation will discuss bringing a new medical device to market in the U.S. and navigating the multiple approvals that are necessary to successfully commercialize a new device. This session will aim to provide a better understanding of the regulators, what regulators expect from manufacturers, and how to develop an effective strategy for an individual product.

"Legal Issues" will discuss the wide range of regulatory matters that affect the successful commercialization of discoveries made in university systems. Mr. Wanerman will be joined by a fellow attorney, and they will address the following topics:

  • Maximizing potential value by building a cost-effective intellectual property foundation
  • Issues and strategies for significant foreign jurisdictions
  • Compliance issues arising under National Institutes of Health (NIH) and National Science Foundation (NSF) grant laws and policies
  • Fraud and abuse risks
  • Coordinating technology transfer into the university‚Äôs compliance program The session is intended to be interactive, and to build on best practices

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