Education

Master of Science in Regulatory Science

The Master of Science (MS) in Regulatory Science provides graduates with the knowledge and skills necessary to contribute to drug regulation and pharmaceutical product lifecycles.

Applications for this exclusively online program are now being accepted, until June 30. Fall semester begins August 25.

What is Regulatory Science?

According to the Food and Drug Administration (FDA), regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The MS in Regulatory Science program at the University of Maryland School of Pharmacy primarily focuses on drugs, although aspects of biologics, diagnostics, devices, and nutritional products are also addressed. The program covers all major areas of drug product regulatory science, including:

  • Chemistry, Manufacturing, and Controls (CMC)
  • Clinical Research
  • Pharmacovigilance
  • Phase IV Research (e.g., Pharmacoepidemiology)
  • Drug Discovery

The strength of the program is its science-driven understanding of drug product development and regulation. The program covers regulatory affairs in a global manner, including the application of regulatory principles worldwide.

Who Should Apply to the Master of Science (MS) in Regulatory Science Program?

This online program is primarily designed for working professionals with Bachelor of Science (BS) degrees who now work in (or would like to work in) regulatory science in industry or government. Working professionals include regulatory affairs associates, scientists in research or development, and clinical associates in clinical affairs or marketed-product support.

What Will I Learn in the Master of Science (MS) in Regulatory Science Program?

Graduates of this program will be fluent in the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. They will possess the knowledge and skills needed to:

  • Devise and implement global strategies for drug, biologic, and device development and evaluation
  • Differentiate USA and other regional requirements for drug product development and registration
  • Apply principles of basic and applied pharmaceutical sciences in drug discovery and development
  • Formulate critical elements of CMC to drug development
  • Relate principles of clinical research design to practices in clinical trial management
  • Apply critical methods of risk assessment and drug utilization from pharmacoepidemiology and post-marketing surveillance, and evaluate economic and sociodemographic factors that influence drug use

With the knowledge and skills obtained through this program, graduates will have access to a number of opportunities in drug research and development, including but not limited to:

  • Regulatory science/affairs positions at pharmaceutical companies, as well as device and biotechnology companies
  • Regulatory science/affairs positions at government agencies, such as the Food and Drug Administration (FDA), National Institutes of Health (NIH), Department of Defense, Biomedical Advanced Research and Development Authority, and the Centers for Disease Control (CDC)
  • Admission into PhD programs

For more information, view website or contact Sharese Essien, Program Manager, MS in Regulatory Science at sessien@rx.umaryland.edu or 410-706-7241.

Individuals who wish to learn more about the MS in Regulatory Science program at UMB and the Certificate program at UMCP are invited to access the following video link:
https://collaboration.fda.gov/p1svb6uzsdp/
 


UMCP Non-Degree Graduate Admission - Advanced Special Student Status

Individuals who wish to participate in M-CERSI educational opportunities at the University of Maryland on a per course basis should complete the application for Advanced Special Student status with the Graduate School.

The Common Web Application (CWA) and $75 application fee will be required. The Application Supplemental Form (ASF) is NOT required for Advanced Special Students.  Click Apply Now for instructions and to begin the application process.

Learn more about this program (doc)


Joint Fellowship Training Program

The National Cancer Institute (NCI), National Institutes of Health, and U.S. Food and Drug Administration (FDA), U.S. Department Health and Human Services (DHHS) are offering fellowship training for Ph.D.s, M.D.s, and M.D./Ph.D.s or their equivalents in cancer-related scientific research and research-related regulatory review.

To learn more about this fellowship, please visit the FDA website.


Interested in Drug Development of Tablet and Capsule Medications?  

Dr. James Polli of the University of Maryland summarizes a workshop report on Facilitating Oral Product Development and Reducing Regulatory Burden through Novel Approaches to Assess Bioavailability/Bioequivalence. See YouTube video.  He also discusses the associated AAPS Journal themed issue.

Non-Degree Graduate Admission - Advanced Special Student Status (pdf)


Establishing and Building Mechanisms for Education and Training

  • Center-Wide Activities
    The M-CERSI builds upon existing collaborations between UM campuses and the FDA. Our center coordinator and two instructional liaisons organize training and public awareness activities.
  • Education and Training Activities - These activities include seminars, quarterly lectures, an annual one-day workshop, the development of new courses, mechanisms for personnel exchange (sabbatical, reverse sabbatical), and graduate student research mentorships.
  • Seminars – These public seminars are held once per quarter on the university campus(es) as part of a regular seminar series focused on bioengineering, pharmaceutical sciences, electrical, and computer engineering, etc.
  • Quarterly Lectures – M-CERSI researchers will present current results and perspectives on their specific regulatory science projects at lectures held at the FDA. These seminars will be open to the UM/FDA M-CERSI community. Each of the three projects will present quarterly lectures.
  • One-Day Workshop – This annual review of each project will include PIs, researchers, and collaborators, as well as members of the M-CERSI Executive Committee.
  • Semester Course – Each M-CERSI project will develop a course for an academic program that is most closely aligned with the research project [e.g., Graduate Program in Life Sciences (GPILS) or Bioengineering (BIOE)]. This course will be offered as a part of the regular academic program and, by design, would include regulatory science and FDA experiences. This may be taught by FDA staff, if available. As the center grows and embraces new projects, new courses would be added to the UM academic programs.
  • Students – Applied research in regulatory science will be carried out by a cadre of talented UM graduate students and post-doctoral fellows. At present, over a dozen BIOE graduate students carry out their research at the FDA. In addition, UM has outstanding undergraduates in its BIOE program, many of whom seek research opportunities during the academic year or as interns during the summer. We have the only joint FDA- and NSF-sponsored Research Experiences for Undergraduates (REU) site in the nation. In this program, 10 undergraduate students from across the US spend 10 weeks during the summer carrying out regulatory science research. These opportunities will expand considerably through the M-CERSI.