Program Overview:

Regulatory Compliance

Regulatory compliance is increasingly visible in healthcare, life science and clinical research arenas. An interdisciplinary professional program, Northwestern University’s part-time MSRC program addresses core areas of compliance, including risk management, quality systems, practices and enforcement, leadership and communication skills. The MSRC curriculum focuses on these core competencies while also stressing practical applications within the program’s three tracks: healthcare compliance, clinical research and quality systems. Graduates are prepared to assume leadership roles in healthcare compliance, clinical compliance administration or quality systems in the pharmaceutical and medical device industries. This breadth of course offerings sets our program apart, as does our partnership with the Northwestern University Feinberg School of Medicine. This affiliation informs the curriculum with the latest insights on healthcare, translational research and regulation.

Regulatory Compliance Faculty Perspective

Karriem S. Watson, MS, MPH
Instructor in the MS in Regulatory Compliance Program and co-founder and co-president of AcaMED Clinical Research Associates. Watson is also a research manager in the neurosurgery department of a major teaching hospital. He also researches community engagement in clinical trials and protocol design, execution and recruitment.

Program Goals

  • Utilize regulatory, risk management and quality systems to assure compliant healthcare, clinical research and pharmaceutical environments.
  • Interpret regulatory requirements and apply them to various roles in healthcare, clinical research and pharmaceutical industries.
  • Create systems and processes to assure compliant quality outcomes.

Program Tracks

Upon admission to the program, students choose one of the following tracks, designed to help effectively develop industry expertise in the these areas:

Curriculum Requirements

The Master of Science in Regulatory Compliance requires completion of 11 courses—four core courses, four track (elective) courses, one cross-elective track course, a leadership course and a capstone project (590). View curriculum details for this program. Current students should refer to curriculum requirements in place at time of entry into the program.

Core Courses:

  • LEADERS 481-0 Leadership
  • MSRC 401-0 Quality Systems
  • MSRC 405-0 Research & Writing
  • MSRC 409-0 Biostatistics
  • MSRC 435-0 Risk and Decision Management
  • MSRC 590-0 Thesis Research

Elective Courses:

  • CLIN_RES 400-0 Clinical Research Essentials
  • CLIN_RES 402-0 Drug and Device Development
  • CLIN_RES 421-0 Clinical Trial Marketing
  • HC_COM 410-0 HC Environment
  • HC_COM 411-0 HC Programs
  • HC_COM 412-0 HC Reg Enforcement
  • HC_COM 413-0 HC Billing Models
  • QARS 420-0 Quality Management
  • QARS 421-0 Regulatory Practices
  • QARS 425-0 QA Project Management
  • QARS 425-0 QA Project Management
  • QARS 450-0 Medical Device Regulations
  • QARS 460-0 Drug and Biologics