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
For more information, visit AUTM.net.