Graduate Education in Regulatory Science

Georgetown University offers graduate-level training in regulatory science. Through its Program for Regulatory Science & Medicine (PRSM), the university offers a unique concentration in regulatory science as part of two master's degree programs.

Students apply the scientific knowledge and analytical capabilities gained in these programs to realize career opportunities in academia, government, and industry. Recent graduates have secured jobs at prestigious organizations conducting regulatory science research; organizations include 23andMe, a subsidiary of Google; Genentech, a worldwide leader in biopharmaceutical innovation; the Qatar National Research Fund, a member of the Qatar Foundation; and the Georgetown University Fellowship in Regulatory Science.

Master of Science in Clinical and Translational Research (MS-CTR)

The MS-CTR provides a foundation in key skills such as applications of bioethics to research, systematic clinical trail design and administration, data collection and analysis, and the methods of behavioral and social sciences. The thematic concentration in Regulatory Science builds on the core curriculum to include elective courses in regulatory science, an applied form of Clinical and Translational Research.

Master of Science in Pharmacology (MS-Pharm)

The Department of Pharmacology & Physiology offers a rigorous program leading to the MS in Pharmacology. The MS Program is designed so that students may complete the program in two full-time semesters. Required courses focus on pharmacology, biochemistry, and physiology. A total of 30 credits are required for the MS-Pharm degree. An area of concentration in Regulatory Science can be chosen, in which case students will take three of the four Regulatory Science concentration electives.  

Regulatory Science Concentration

The Regulatory Science concentration is appropriate for trainees who are interested in developing (1) broad understanding of regulatory science applications to public health, (2) enhanced analytic skills and methods for evidence-based decision-making, (3) an understanding of the role of novel technologies, tools, and approaches to assessing safety and quality of medical, food, or tobacco products, and (4) behavioral and social science skills in communicating risk and benefit.

The Regulatory Science concentration includes didactic instruction, student-led and mentored exercises, experiential learning opportunities, and discussion in carefully structured courses.

Candidates will hold or currently pursue medical, master, or terminal degrees in related disciplines, ensuring that courses will be taught with a high level of rigor. Successful degree candidates will apply scientific knowledge and analytical capabilities and realize career opportunities in academia, government, or industry.


MS-CTR Core Curriculum

  • Research Ethics & Human Subjects (3)
  • Introduction to Biostatistics in Clinical Research (3)
  • Study and Clinical Trial Design (2)
  • Project Development in Clinical Research (1)
  • Epidemiologic Methods (3)
  • Clinical Research Administration (2)
  • Social and Behavioral Aspects of Public Health (3)
  • Core Clinical Research Seminars (1)
  • Elective Courses (10)
  • Capstone Research Project (4)

MS-Pharm Core Curriculum

  • Principles of Pharmacology (4)
  • Fundamentals of Physiology (4)
  • Cell and Molecular Physiology (4)
  • Graduate Pharmacology (10)
  • Elective Courses (7)

Georgetown University Elective Courses in Regulatory Science

Course Name

Course Number

Credit Hours

Period

Introduction to Regulatory Science (flipped classroom)

PHAR620

2 credits

Fall

Research Ethics with Human Subjects (online)

CLTR501

3 credits

Fall

Analytic Approaches for Regulatory Science (online)

CLTR900

3 credits

Spring

Approaches for Assessing Safety, Quality, and Benefit (online)

CLTR904

3 credits

Spring

Communicating Risk and Benefit for Public Health (online)

CLTR905

2 credits

Spring

Public Policy for Scientists

MICB606

4 credits

Fall

Regulatory Science and Public Health

MICB702

2 credits

Fall

Science Diplomacy and World Health

MICB705

2 credits

Spring

Introduction to Pharmacology / Toxicology

PHAR584

2 credits

Fall

Systems Concepts and Drug Safety

PHAR840

2 credits

Spring

Regulatory Pharmacokinetics

PHAR842

3 credits

Spring

Aspects in Drug Development (online)

CLTR700

3 credits

Spring

Introduction to Bioinformatics

BCHB515

1 credit

Spring

Drug Targets / Drug Design

BCHB522

2 credits

Spring

Note: Georgetown RS graduate course offerings allow for completely online or onsite learning, or a hybrid of the two. These modalities provide diverse students with learning opportunities that best fit their professional and personal commitments, all while preserving meaningful and effective learning experiences. 


Flexible Format and Diversity

The Regulatory Science concentration is designed to meet the needs of professionals from various backgrounds, including science, medicine, public health, public policy, business, or law. Faculty will come from Georgetown and Howard Universities, other academic centers, government (FDA, NIH), and the medical product industry (pharmaceuticals, biologics, devices).

The concentration includes flexible courses that are offered exclusively online to meet the needs of students who are also full-time working professionals, or those who do not live in the DC metropolitan area. 

Future offerings will include a Graduate Certificate in Regulatory Science.

Where Graduates Are Working
  • Google (Mountain View, California, US)
  • Qatar National Research Fund (Doha, Qatar)
  • Genentech (South San Francisco, California, US)
  • Georgetown University Program for Regulatory Science & Medicine (Washington, DC, US)
Application Requirements

Apply for the MS in Clinical and Translational Research, Regulatory Science concentration using our online application form

Applications are accepted for Fall (deadline June 30) or Spring (December 1) semesters.

  • Application form
  • Non-refundable application fee – $80
  • Statement of purpose – A personal statement describing past exposure to clinical and translational science or regulatory science, reasons of interest in the program, and career goals
  • Resume/CV
  • Recommendations – 3 written recommendations, sent to mailing address below
  • GRE – not required; may opt to submit GRE scores to address below
  • TOEFL/IELTS (see below)
  • Official transcripts (all prior institutions) – mailed to the following address:

Cost of attendance 

Georgetown University
Office of Biomedical Graduate Education
NE303 Medical-Dental Building
3900 Reservoir Road, NW
Washington, DC 20057-1411 

TOEFL/IELTS: All applicants are required to demonstrate a level of proficiency in the English language sufficient to meet the admission requirements of the Graduate School of Arts and Sciences. Proficiency can be demonstrated by: 1) receipt of a bachelor’s or advanced degree from a U.S. accredited institution of higher learning or from a university where English is the primary language of instruction (please note: applicants receiving degrees from universities in U.S. territories where English is not the primary language are required to submit TOEFL or IELTS unless the primary language of instruction is English); or 2) clinical training or a full-time clinical faculty/staff appointment at a U.S. hospital. All other applicants must achieve at least a minimum score on either the TOEFL or IELTS test. Test scores must be received by the application deadline. Applicants should allow 6 to 8 weeks from the test date for the reporting of scores to the institution.

**Please note: This program is not eligible to issue immigration documents to non-U.S. citizens.

Contact 

Erin Wilhelm, MPH
Executive Director, Program for Regulatory Science & Medicine
Assistant Professor of Pharmacology & Physiology
Georgetown University
eew6@georgetown.edu