Program Overview

Overview of the Online Doctor of Professional Practice (DPP) in Regulatory and Clinical Research Management

The Doctor of Professional Practice (DPP) in regulatory and clinical research management is designed to equip students with the knowledge and skills necessary to lead at the forefront of the discovery and advancement of medical products. This program will complement students' leadership experience in regulatory or clinical research management and enable them to strategically bring medical products to market.

Program Details

• Total classes: 17
• Weeks per class: 7.5
• Total credit hours: 60
• Next start date: 08/20/2026

What You'll Learn

In this first-of-its-kind program, students will learn about a leader's role in developing new medical products efficiently. The courses will focus on building research, writing, and leadership skills needed to navigate the complexities of medical product development. Key topics include quality control and assurance, responsible conduct and ethics, development and regulation of biologics, and more.

Core Courses

• Development and Manufacturing Small Molecules: Covers the steps involved in drug discovery and development, focusing on typical small-molecule drugs.
• Development and Regulations of Biologics: Explores biologic drugs, including their lifecycle, manufacturing and delivery options, regulatory outlook, and bioanalysis during development.
• Leadership in the Medical Product Industry: Examines theories and strategies of innovative leadership related to improving the pharmaceutical and medical device industry.
• Pharmacology, Drugs and Society: Discusses the impact of major drug discoveries on the practice of medicine and the health of society as a whole.
• Planning and Execution of Clinical Research Studies: Applies project planning methods, business practices, and ethical considerations in planning successful clinical trials.
• Quality Control and Assurance Through the Medical Product Cycle: Focuses on the role quality control and assurance play during drug development and commercialization.
• Responsible Conduct and Ethics in Regulatory Affairs: Reviews bioethics and policies related to human subject research.
• Writing for Research Industry: Teaches how to apply written, oral, and interpersonal communication theory in the business environment.

Career Opportunities

This doctoral degree prepares students for advanced leadership opportunities in regulatory and clinical research practice settings. Career examples include:

• Clinical data manager
• Clinical operations director/manager
• Compliance officer/manager
• Director/manager post-market quality
• Director/manager quality control
• Director/manager quality management
• Director/manager of regulatory affairs
• Program/project director manager

Admission Requirements

• Minimum GPA: 3.00 cumulative GPA in an applicable master's program
• Application requirements:
  • Graduate admission application and application fee
  • Official transcripts
  • Personal statement
  • Up-to-date curriculum vitae or resume
  • Two professional letters of recommendation
• Additional admission information:
  • An applicant whose native language is not English must provide proof of English proficiency
  • On the application, applicants will have an opportunity to provide an example of a published paper or graduate-level scientific paper (optional)
  • Please note additional program fees may apply

Tuition and Fees

Use the tuition calculator to estimate full-time or part-time tuition fees for this program prior to any financial aid. Most students receive financial aid, which can reduce out-of-pocket costs. Learn more about estimating tuition and fees.

About the Edson College of Nursing and Health Innovation

The Edson College of Nursing and Health Innovation provides a world-class education to students across various health disciplines. The college distinguishes itself by delivering excellent programs and challenging courses led by high-quality instructors. With 26+ undergraduate, graduate, and certificate programs online, 334 faculty members, $59 million+ in research expenditures, and 7,000+ students, the college is committed to preparing the health leaders of tomorrow.