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St. Cloud State University

St. Cloud State University

Graduate Bulletin Table of Contents

Regulatory Affairs and Services Graduate Program (RAS)

Offered through the Academic Center for Regulatory Affairs and Services
in the College of Science and Engineering
145 Wick Science Building
Phone: 320.308.2192
Fax: 320.308.5124
Email: COSE@stcloudstate.edu

Interim Director/Graduate Coordinator: Dr. Bruce Jacobson
Interim Contact secretary: Mary Fugleberg
Graduate Faculty: Baliga, Jacobson and consulting faculty based on course offerings

The Master of Science degree in Regulatory Affairs and Services [M.S. RAS] focuses on the specific educational and career development needs of employees responsible for managing the required regulatory approval processes in the medical device industry.  The intent of the program is to prepare students to take leadership roles within the regulatory departments of medical device organizations.

The Profession

The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to state, federal, and international medical device regulations for safety and efficacy. In successful medical device companies, regulatory professions are involved in all stages of the commercialization process from initial business planning to design, development, verification, pre-clinical, clinical, manufacturing, packaging, labeling, marketing, and post market surveillance. 

The regulatory profession requires versatile individuals with excellent communications skills and a broad knowledge of the following: science and engineering, state, federal, and international regulations; planning, and risk management. As the success or failure of medical device businesses increasingly depend on regulatory affairs, clinical and reimbursement strategies, and implementation, regulatory professionals must take leadership roles within medical device organizations. Thus the demand for well trained and skilled regulatory professionals in the medical device industry is growing significantly.

Program Overview

The Master of Science degree in Regulatory Affairs and Services program [M.S. RAS] provides the means to develop the essential understanding and competencies to work in the regulatory affairs of medical device manufacturers or consulting organizations. It provides experience and relevant training in three broad areas of regulatory affairs and services: 

  • Regulatory Affairs
  • Clinical Trials and Quality Systems
  • Health Economics and Reimbursement

Designed to meet the specific needs of working professionals, courses are held evenings and weekends at North Hennepin Community College in the Twin Cities.

NOTE: The program started in early October 2007, with the first cohort taking (RAS 62) Basis for Medical Device Product Regulation and (RAS 63) Clinical Study Design, Implementation, and Analysis. These courses are offered again for the second cohort starting in late January 2008. In the second semester of the program, the first cohort will take (RASW 625) Regulatory Submissions/Application Requirements for Medical Devices: Routes to Market and (RAS 641) Health Policy and the Medical Technology Industry.

Degree and Plans Offered

  • Master of Science (non-thesis) Plan B at 33 credits – Final paper required

Admission Requirements Specific to the Program

  • An undergraduate degree in engineering, biochemistry, bio statistics, public health, nursing, or other appropriate and relevant area is recommended as a basis for successful completion of the RAS degree.
  • The director and instructors from the Center for Regulatory Affairs and Services will review applicants to ensure each candidate's qualifications.  

Length of Program – Measured by Semesters

  • Part-time student -six semesters.

Program location and time

The program will be offered at North Hennepin Community College located in Brooklyn Park, MN. For a map and location go online to: http://www.nhcc.edu/maps/display.cfm?article=1000295.

  • For the fall 2007 semester, RAS 621 is taught Monday evenings from 5:30 p.m. to 9:30 p.m., and RAS 631 is taught Saturdays from 9:00 a.m. to 1:00 p.m.
  • The spring 2008 semester will start on Saturday, January 26 and courses will be taught again on Monday evenings and Saturday mornings.
  • The program started in early October 2007, with the first cohort taking (RAS 62) Basis for Medical Device Product Regulation and (RAS 63) Clinical Study Design, Implementation, and Analysis. These courses are offered again for the second cohort starting in late January 2008.
  • In the second semester of the program, the first cohort will take (RASW 625) Regulatory Submissions/Application Requirements for Medical Devices: Routes to Market and (RAS 641) Health Policy and the Medical Technology Industry.
  • Computer lab, classrooms and breakout areas will be available for this program.
  • Students will have full access to electronic recourses via a HuskyNet account and instruction will be provide by course management software, currently D2L. 

Tuition

Cost of tuition for this opportunity will be $750 per credit for the 2007-2008 academic year.

To Apply

ONLINE: Complete the School of Graduate Studies online application at : http://www.stcloudstate.edu/gradadmissions/us_admissions/default.asp.

TRIED and TRUE: If you prefer to receive a good old fashion paper application packet please contact the School of Graduate Studies.

DEADLINE: The deadline to apply for spring semester 2008 is January 7, 2008.

School of Graduate Studies
Telephone: 320.308.211
Toll free: 1.800.369.4260
E-mail: graduatestudies@stcloudstate.edu


Master of Science in Regulatory Affairs and Services

Plan B, 33 credits

Regulatory Affairs

RAS 621. Legal Basis for Medical Device Product Regulation, 3 credits
RAS 623. Investigational Medical Device Regulations, Standards, and Guidelines, 3 credits
RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market, 3 credits
RAS 627. International Regulatory Affairs: European Union, Canada, Japan, and Australia, 3 credits

Clinical Trials and Quality Systems

RAS 631. Clinical Study Design, Implementation, and Analysis, 3 credits
RAS 633. Quality Systems for Regulated Industries, 3 credits
RAS 635. Regulatory Affairs Compliance, 3 credits

Health Economics

RAS 641. Health Policy and the Medical Technology Industry, 3 credits
RAS 643. Cost Management of Regulated Health Care Technology, 3 credits
RAS 645. Reimbursement for Medical Technology, 3 credits

Culminating Experience

RAS 690 Regulatory Affairs Culminating Project, 3 credits
May take course over one to three semesters, for a total of 3 credits required for degree completion

Course descriptions

RAS 621. Legal Basis for Medical Device Product Regulation
Upon completion of this course the students will be knowledgeable about the objective and structure of the FDA, key regulations associated medical devices, and the resources available from the FDA to aid in compliance with those regulations  3 credits.

RAS 623. Investigational Medical Device Regulations, Standards and Guidelines  
Pertinent ethical, industrial, and federal standards and guidelines governing the implementation of medical experiments will be discussed.    Specific topics to be addressed include investigational device exemptions, humanitarian use of medical devices, and emergency use of unapproved medical products.  3 credits.

RAS 625. Regulatory Submission/Application Requirements for Medical Devices:  Routes to Market
Reviews the laws and federal regulations that are applicable to medical devices in the United States .The medical device classification process will be discussed.  Prerequisite RAS 621. 3 credits.

RAS 627. International Regulatory Affairs: European Union (EU), Canada, Japan, and Australia
Reviews the authorization procedures that are applicable to medical devices that are scheduled to be marketed in the following international markets:  European Union (EU), Canada, Japan, and Australia.  The routes to market will be outlined.  Prerequisite RAS 621.  3 credits.

RAS 631. Clinical Study Design, Implementation, and Analysis  
Presents the epidemiological and bio statistical principles underling clinical research of medical devices.  The most common study designs used to evaluate medical devices are presented. Prior course in Introductory Statistics or Bio statistics is desirable. 3 credits.

RAS 633. Quality Systems for Regulated Industries  
Training in the content and scope of Quality Systems necessary to be an effective participant/leader in the regulated medical device industry including the evolution of quality system requirements and current perspectives on the interpretation of standards.  3 credits.

RAS 635. Regulatory Affairs Compliance  
Students will be knowledgeable about the regulations associated with device product listing, facility registration, product complaint management, aware of other considerations associated with compliance such as liability, root cause analyses, effective communication, and ethical considerations. Prerequisite RAS 633.  3 credits.

RAS 641. Health Policy and the Medical Technology Industry  
Historical perspective of the role of health policy in the development and diffusion of medical technology.  Policy issues will be framed in the context of promoting versus inhibiting technology development and diffusion.  A major portion of this class will be devoted to analysis and critique of current and proposed health policies as they affect the medical technology industry.  3 credits.

RAS 643. Cost Management of Regulated Health Care Technology
Upon completion of the course, student will be able to describe the four basic types of economic evaluations and their intrinsic components,  be able to describe the modifications required based upon the perspective of the evaluation  and critically appraise a published economic analysis of a medical technology.  Prerequisite RAS 641.  3 credits.

RAS 645. Reimbursement for Medical Technology
Covers overview of requirements for reimbursement for medical devices.  Students will understand the relationship between the three components of reimbursement: coverage, coding, and payment.  Students will be able to state the basic components required to assess reimbursement for a new technology and be able to draft a preliminary strategy for gaining reimbursement. Prerequisite RAS 631. 3 credits. 

RAS 690. Regulatory Affairs Culminating Project
Culminating experience: research project, starred paper, and seminar. Student will develop, carry out and report [in written and oral format] on an individual research project related to the content of the program courses. Project requires approval of instructor. Students may take course over one to three semesters, for a total of 3 credits required for degree completion

To prospective students
We suggest you visit the School of Graduate Studies Web site: www.stcloudstate.edu/graduatestudies/

The steps required to apply for admission to SCSU are outlined at: http://bulletin.stcloudstate.edu/gb/admission/programs.asp#masters

The following Web sites provide admission requirements and a checklist for graduate admissions: http://bulletin.stcloudstate.edu/gb/admission/admission.asp#admintest   

If you have further questions please contact:College of Science and Engineering at 320-308-2192 or COSE@stcloudstate.edu