Program Overview

Master of Science in Health Sciences in the Field of Regulatory Affairs and Clinical Research Leadership

The Master of Science in Health Sciences in the Field of Regulatory Affairs and Clinical Research Leadership is a dynamic and emergent field that brings together the science in which products—drugs, devices, biologics, and vaccines—and treatment protocols are developed for improved global healthcare. The program prepares scientists and regulatory professionals to manage the key elements of the clinical research regulatory process.

Overview

The rigorous curriculum focuses on regulatory strategy, regulatory guidance, legal and ethical issues, processes for product development, and the business and political components of regulation in clinical research, all while reinforcing the science behind the methods. Program graduates develop knowledge and skills in regulatory strategy and clinical conduct to guide the development of new therapeutics.

The distance education format provides a contemporary option for self-directed professionals who work in the field with industry or who might be just entering the field with one of the health and human services agencies charged with providing oversight and guidance to industry. Our coursework has been developed in partnership with colleagues in industry and public regulatory agencies.

Admissions

• Admissions Deadlines:
  • Fall: July 20
  • Spring: December 1
  • Summer: March 20
• Standardized Test Scores: Not required
• Recommendations required: Two (2) letters of recommendation
• Prior Academic Records: Official transcripts are required from all colleges and universities attended
• Statement of Purpose: In an essay of approximately 250-500 words, describe your interest in undertaking study at The George Washington University
• Degree and GPA Requirements: Bachelor's degree from a regionally accredited institution, Cumulative GPA of 3.0 or above on a 4.0 scale
• Previous work experience: Health care related experience preferred
• International applicants: International students should check with individual programs regarding eligibility for visa sponsorship

Requirements

The following requirements must be fulfilled: 36 credits, including 21 credits in required core courses and 15 credits in required and elective courses in either the regulatory affairs concentration or the clinical research administration concentration.

• Required core courses:
  • HSCI 6264: Epidemiology Translational Research
  • COHM 6235: Leadership Development in Healthcare Systems
  • COHM 6245: Strategic and Operational Decision Making for Healthcare Leaders
  • RCR 6201: Introduction to Global Regulatory Affairs and Clinical Research
  • RCR 6202: Regulatory Strategy in the Development of Therapeutics
  • RCR 6206: International Regulatory Affairs and Clinical Research
  • RAFF 6275: Leadership in Regulatory Affairs
  • or CRA 6275: Leadership and Change in Clinical Research Administration
• Concentration requirements:
  • Students must complete all requirements for either the regulatory affairs concentration or the clinical research administration concentration
  • Regulatory affairs concentration:
    • Required:
      • RAFF 6203: Regulatory Strategy in the Development of Devices and Diagnostics
      • RAFF 6204: Clinical Research for Regulatory Affairs
      • RAFF 6205: Regulatory Affairs Compliance
      • RAFF 6207: Advertising and Promotion of Regulated Medical Products
    • And one course selected from the following:
      • CRA 6203: Partnerships with Human Subjects
      • CRA 6209: Quality and Risk Management
      • CRA 6211: Monitoring, Auditing, and Oversight in Clinical Research
      • HSCI 6263: Biostatistics Translational Research
  • Clinical research administration concentration:
    • Required:
      • CRA 6203: Partnerships with Human Subjects
      • CRA 6204: The Clinical Research Industry
      • CRA 6209: Quality and Risk Management
      • CRA 6211: Monitoring, Auditing, and Oversight in Clinical Research
    • And one course selected from the following:
      • HCQ 6201: Building a Quality Culture
      • HSCI 6263: Biostatistics Translational Research
      • RAFF 6204: Clinical Research for Regulatory Affairs
      • RAFF 6205: Regulatory Affairs Compliance
      • RAFF 6207: Advertising and Promotion of Regulated Medical Products