Education

Master of Science in Regulatory Science

The University of Maryland School of Pharmacy has established a new Master of Science (MS) in Regulatory Science to provide students with the knowledge and skills necessary to contribute to drug regulation and pharmaceutical product lifecycles.

With an emphasis on drug discovery, drug development, clinical research, and post-approval drug regulation, this part-time, non-thesis program is designed for working professionals who currently work, or would like to work, in regulatory science.

Applications are currently being accepted for Spring 2014 (i.e. January 2014). The application deadline is December 1, 2013. 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 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)


** New Course Fall 2013  **

BIOE 689R Introduction to Regulatory Affairs: Devices and Drugs (3 credits)

Course Description: This course provides an introduction to regulatory affairs as related to US FDA regulation of devices and drugs. It covers a summary of the FDA procedures necessary to obtain FDA approval of devices and drugs. It covers a summary of ethical and legal issues related to regulatory affairs. It touches on the relationship between regulatory affairs and science and engineering, highlighting the opportunities for technical input to the regulatory process.

To learn more about this course, please view this document.


FDA Commissioner's Fellowship Program

FDA invites outstanding healthcare professionals, scientists, and engineers to apply to its two-year Fellowship Program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific or regulatory issues under the mentorship of an FDA senior scientist.

Class of 2013 Application Process Key Dates

  • Application period for the CFP Class of 2013:
    Applications will be accepted starting April 16, 2013 through May 25, 2013 5pm EST. Letters of recommendation will be due June 4th by 5pm EST.
  • Late June/July – Interviews
  • July through August – Applicants Notified
  • October – Program Start Date

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


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 UM-CERSI builds upon existing collaborations between UM campuses and the FDA. Our center coordinator and two instructional liaisons organize training and public awareness activities.
  • CERSI Day
    The center will sponsor an annual CERSI Day, during which all participants, affiliates, and other interested parties will share results, ideas, suggestions, and concerns. It will be a broadly advertised forum for regulatory science exchange. The inaugural CERSI Day is scheduled for September 5, 2012. All participants, including the public, will be encouraged to become active in Center activities via a network of experts, the industrial consortia, sponsors and collaborators engaged in research projects, and participants in CERSI-related educational opportunities.
  • 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 – 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-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 CERSI Executive Committee.
  • Semester Course – Each 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 UM-CERSI.
UMD, UMB, FDA

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