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What is Investigational New Drug (IND) Application

Preparing Physicians to Lead in the 21st Century
The US Food and Drug Administration (FDA) requires a sponsor to submit an IND before they can conduct a clinical investigation with and new product. This requirement is based on the Code of Federal Regulations (CFR) 21.
Published in Chapter:
Team Building and Function in a Physician Leadership Program
Anthony DelConte (Saint Joseph's University, USA) and Michael J. Gast (Saint Joseph's University, USA)
Copyright: © 2019 |Pages: 20
DOI: 10.4018/978-1-5225-7576-4.ch008
Abstract
Among the critical skills to be developed in a physician leadership program are teamwork and collaboration. The team approach to the design, execution, and implementation of healthcare programs should be stressed. To encourage this approach in our physician leadership program, the authors use team structure as an essential component of classroom structure to encourage completion of real-world projects and assignments relevant outside of the classroom environment. This chapter demonstrates how teams were formed and evaluated in courses involving the marketing of healthcare systems services and healthcare system mergers and acquisitions. This chapter also describes components in the development and implementation of a clinical leadership MBA curriculum designed to provide physician-leaders with a strategic perspective on healthcare decision making that encompasses a broad range of structural, technological, financial, cultural, and ethical considerations.
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