Cover/Signature Page – Full Template
Institution Submitting Request: Utah Valley University
Proposed Title: Graduate Certificate in Regulatory Affairs for Life Sciences
School or Division or Location: College of Science and Health
Department(s) or Area(s) Location: Department of Biology
Recommended Classification of Instructional Programs (CIP) Code1 30.0101
Proposed Beginning Date: 08/01/2014
Institutional Board of Trustees’ Approval Date: 02/13/2014
Proposal Type (check all that apply):
Regents’ Agenda Items
R401-4 and R401-5 Approval by Committee of the Whole
SECTION NO.
4.1.1
(AAS) Associate of Applied Science Degree
(AA) Associate of Arts Degree
4.1.2
(AS) Associate of Science Degree
4.1.3
Specialized Associate Degree
4.1.4
Baccalaureate Degree
4.1.5
K-12 School Personnel Programs
4.1.6
Master’s Degree
4.1.7
Doctoral Degree
5.2.2
(CER C) Certificate of Completion
5.2.3
x
Graduate Certificate
5.2.4
Fast Tracked Certificate
ITEM
Chief Academic Officer (or Designee) Signature:
I certify that all required institutional approvals have been obtained prior to submitting this request to the Office of the
Commissioner.
______________________________________
Signature
Date: 02/03/2014
Printed Name: Ian Wilson
1
CIP codes must be recommended by the submitting institution. For CIP code classifications, please see http://nces.ed.gov/ipeds/cipcode/Default.aspx?y=55.
Updated 12/20/2013
Executive Summary – Full Template
Utah Valley University
Graduate Certificate in Regulatory Affairs for Life Sciences
12/20/2013
Program Description
The Regulatory Affairs for Life Sciences Graduate Certificate program will provide students with the skills required to
interpret and manage regulatory and quality compliance issues that are critical for the Life Sciences. The curriculum
materials include formal studies that are specific to regulatory sciences (domestic and international), quality management
system, and design control. Students will gain experience in technical communications with an emphasis on the theory and
practice of technical writing as it relates to industry-based submissions. Students will participate in an internship or capstone
project with a medical device, pharmaceutical, diagnostics, or biotechnology company. A baccalaureate degree in a science
or a technology-related area of study will be required.
Role and Mission Fit
The UVU mission statement states, “The University prepares professionally competent people of integrity who, as lifelong
learners and leaders, serve as stewards of a globally interdependent community.” There is clear demand for competent
regulatory affairs talent in the work force. The ability to gain regulatory affairs skills will bring value to those with existing
baccalaureate degrees and help them to contribute to a growing life sciences industry. The university and the students
benefit by contributing to the growth of companies in their community and ultimately the regional economy.
Faculty
The skills required for regulatory affairs are not associated with traditional academic programs or research efforts at most
universities. The skills and aptitudes are specific to industry and bringing products to market. Thus, it is not typical that
universities will have faculty members with the ability to teach in regulatory affairs. Dr. Goetz, in the Dean’s Office, has
sufficient knowledge to have provided the initial guidance for program design, course development, and creation of the
certificate proposal.
A Director for the proposed program was recently hired. Dr. Haven McCall has a D.R.Sc. and M.S. in Regulatory Sciences
from the University of Southern California and an M.S. in Business Management from Northern Arizona University. He has
13 years of experience working for global life science companies in the areas of regulatory affairs (domestic and
international), quality, clinical research, and product surveillance. His work experience gives him a broad base of skills,
which make him an adept leader that is able to build and manage programs and teams, develop budgets, and create
strategic plans. Dr. McCall has spent the last several years helping to design and teach graduate level courses in
Regulatory Affairs at Arizona State University. Finally, his participation in a national consortium of university regulatory
affairs programs will help to build credibility to the new UVU program.
Dr. McCall, as the Director, will teach BIOL 5000, BIOL 579R, and portions of BIOL 5010 and 5020. He will oversee and
monitor the internships (BIOL 581R) and the Capstone projects (BIOL 580R). One adjunct instructor will co-instruct BIOL
5010 and 5020. A faculty member from the English Department will teach ENGL 5340. It is not anticipated that additional
full-time faculty members will be needed. New faculty members will participate in all required training and orientation and
remain current on program subject matter through ongoing industry relations.
Market Demand
The Utah Department of Workforce Services (DWS) Labor Market Information (LMI) reports an average of 70 jobs posted
annually for regulatory and compliance. These jobs are listed as “five stars” which indicates a job area with the strongest
employment outlook and highest wages. Battelle generated a report for the Utah Cluster Acceleration Partnership (UCAP)
Updated 12/20/2013
program in August of 2012, which indicated that there would be an annual projected growth of approximately 60-70 new
hires in these regulatory and compliance positions over the next five years. The UCAP report independently confirmed,
through interviews with industry representatives, that a current critical shortage of skilled regulatory affairs professionals is
adversely affecting their ability to develop and bring their medical products to market. A search conducted on several
websites2 listed a total of 17-25 jobs posted for regulatory affairs positions in Utah. The positions ranged from entry-level to
managerial and all of them required a baccalaureate degree. The majority of the posted positions were with life science
companies; a few were associated with technical talent agencies (“headhunters”) and law firms. It is important to note that
the Utah life science industry continues to grow at approximately two percent annually, and it is one of two Utah industries
that did not experience a reduction or even flattening of job growth during the economic decline. Further, it is anticipated
that the increase in Federal Drug Administration (FDA) oversight of the natural products and dietary supplement industry will
result in a need for additional regulatory talent. This creates a compelling reason to create a new certificate to help the
industry meet current and projected needs for its continued growth.
Student Demand
While there is no program available currently for regulatory affairs (in UVU or Utah), two courses have been developed and
were piloted during the Fall of 2013. There were 24 inquiries into the courses, with the majority of the inquiries from current
employees in Utah companies. Student demand is projected to be high, especially for biology graduates. The certificate will
add considerable value to an existing baccalaureate degree. The employment opportunity will be high, there will be
increased job security, and a significant increase in wages for those with regulatory affairs skills. There were 90 biology
graduates (plus 22 from chemistry and biotechnology) that graduated with a baccalaureate degree in 2012. There are a total
of 681 biology majors enrolled at UVU, with 349 of these students being seniors. Biology Department advisors estimate,
based upon their experience, that 10-15 students will enroll annually in the program. There is a more than adequate pool of
prospective students at UVU, and it is anticipated that with advertising of the program there should be significant interest for
students at other institutions of higher education. It is expected that there will be considerable interest in the program by
existing employees in Utah life science companies.
Statement of Financial Support
Appropriated Fund………………………………………………….
Special Legislative Appropriation…………………………………
Grants and Contracts………………………………………………
Special Fees ……………………………………………………….
Differential Tuition (must be approved by the Regents)………..
Other (please describe)……………………………………………
Similar Programs Already Offered in the USHE
A benchmarking study was performed by the UCAP Life Sciences Talent Committee to determine where and to what extent
related programs exist in other states. The study found 43 other regulatory programs offered by higher education
institutions, none within the State of Utah. Of these programs, 22 offer master’s programs and 27 offer certificate programs.
The College of Engineering at the University of Utah offers a course in design control; however, it is specific for engineering
majors.
2
Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)
Updated 12/20/2013
Program Description – Full Template
Utah Valley University
Graduate Certificate in Regulatory Affairs for Life Sciences
12/20/2013
Section I: The Request
Utah Valley University requests approval to offer a Graduate Certificate in Regulatory Affairs for Life Sciences effective Fall
2014. This program was approved by the UVU Board of Trustees on 02/13/2014.
Section II: Program Description
Complete Program Description
The Graduate Certificate in Regulatory Affairs for Life Sciences will provide students with the education required to interpret
and manage regulatory and quality compliance issues that are critical to the Life Sciences. The curriculum materials include
formal studies that are specific to regulatory sciences (domestic and international), quality management system, and design
control. Students will gain experience in technical communications with an emphasis on the theory and practice of technical
writing as it relates to industry-based submissions. Students will participate in an internship or capstone project with a
medical device, pharmaceutical, or diagnostics company. A baccalaureate degree in a science or technology-related area of
study will be required.3
Purpose of Degree
The program builds on an education pathway that provides a course of study designed to prepare students for excellent
career employment opportunities in regulatory affairs. The course content is designed for students who already have a
baccalaureate degree in biology, biotechnology, or chemistry, and for advanced undergraduate students who are nearing
completion of a baccalaureate degree in these disciplines. Students pursuing two-year degrees in Biology, Chemistry,
Biotechnology and Biomanufacturing are on an educational pathway preparing them for regulatory affairs training when they
reach the graduate or advanced undergraduate level. It will also provide additional skills to current employees that are
seeking new opportunities within the life science industry. All required courses are at the 5000 level, which accurately
reflects the fact that all are advanced courses appropriate for graduate students but also available to qualified advanced
undergraduate students who choose to enhance their undergraduate training as they near completion of the baccalaureate
degree.
The UVU College of Science and Health reported 112 graduates in biology, chemistry, and biotechnology in 2012. The
proposed certificate will give a valuable post-baccalaureate option to these graduates, as well as graduates from other
institutions. The College has significant relations with local industry partners and is well aligned to place students into
internship and employment opportunities to these graduates.
The Graduate Certificate in Regulatory Affairs for Life Sciences will be the only program of its type in the Intermountain
West region. It will provide a unique opportunity for qualified students to access careers that are in high demand in Utah
companies. The long-term goal is to create a program that has robust enrollments, graduate-level content, and instruction
that is of optimal quality. We anticipate highly effective job placement and satisfaction by graduates and employers.
Updated 12/20/2013
Institutional Readiness
The College of Science and Health and the Department of Biology are poised to administer the full, proposed program.
Funding has been provided from the Utah Cluster Acceleration Partnership (UCAP; funding administered through the Utah
System of Higher Education and the Utah Department of Workforce Services) to develop and deliver new pilot courses in
regulatory affairs through June 30, 2015. This funding includes support for curriculum material development for the new
courses, salaries for a full-time instructor (who will also provide administrative support for the new courses), adjunct
instructors, and supplies.
The University and College administration are working to build the cost of the proposed program into the institutional budget
beginning July 1, 2015. The proposed program will enroll 20-25 students per year, which will not put significant additional
burden on Student Services (Registration and Records, Academic Advising, Financial Aid, Graduation Office) and other
administrative support units (e.g., scheduling). This enrollment projection is based upon anticipated student demand and the
cap is determined by program capacity that will ensure quality instruction.
The curriculum materials have been developed and incorporated into courses, which are embedded into a one-year
sequence for the proposed certificate. Utah Valley University (UVU) faculty designed the course content with significant
input from industry experts, to ensure quality, rigor, relevance, and accuracy of content. Faculty members and
administration from higher education partners (UVU, Salt Lake Community College, and the University of Utah) provided
limited content input and ensured that the courses were developed in adherence to academic rigor and format.
Departmental Faculty
Faculty Category
With Doctoral Degrees (Including MFA and other terminal
degrees, as specified by the institution)
Full-time Tenured
Full-time Non-Tenured
Part-time Tenured
Part-time Non-Tenured
With Master’s Degrees
Full-time Tenured
Full-time Non-Tenured
Part-time Tenured
Part-time Non-Tenured
With Baccalaureate Degrees
Full-time Tenured
Full-time Non-Tenured
Part-time Tenured
Part-time Non-Tenured
Other
Full-time Tenured
Updated 12/20/2013
Faculty
Headcount –
Prior to
Program
Implementation
Faculty
Additions to
Support
Program
Faculty
Headcount at
Full Program
Implementation
17
5
17
5
2
2
0
0
9
0
0
1
9
0
1
0
0
0
13
13
0
0
Full-time Non-Tenured
Part-time Tenured
Part-time Non-Tenured
Total Headcount Faculty
Full-time Tenured
Full-time Non-Tenured
Part-time Tenured
Part-time Non-Tenured
Total Department Faculty FTE (As reported in the most recent
A-1/S-11 Institutional Cost Study for “prior to program
implementation” and using the A-1/S-11 Cost Study Definition for
the projected “at full program implementation.”)
0
0
17
1
17
5
9
32
38
18
17
6
9
33
X
38.70
Most of the skills required for regulatory affairs are not associated with traditional academic programs or research efforts at
universities. The skills and aptitudes are specific to industry and its efforts to bring products to market. Thus, it is unusual for
universities without a regulatory affairs program to have faculty members with the ability to teach in regulatory affairs.
Nonetheless, where such programs exist, there is strong support from industry partners. Many industry experts are willing to
teach in adjunct positions, providing content that is often not present in traditional academic programs. Such experts from
industry possess the ability to teach graduate-level material, enabling students to apply and analyze knowledge in complex
situations. UVU has developed the necessary relationships with industry partners to implement and support this program of
study.
A new Director, Dr. Haven McCall, (Scholar-in-Residence; faculty position) was hired to oversee the implementation and
management of the program, including supervision of adjunct instructors. The Director will teach BIOL 5000, BIOL 579R
and portions of BIOL 5010 and 5020. The Director will oversee and monitor the internships (BIOL 581R) and the capstone
projects (BIOL 580R). One adjunct instructor will co-instruct BIOL 5010 and 5020. New faculty will participate in all required
training and orientation and remain current on program subject matter through ongoing industry relations.
The requirements for the adjunct instructor will be equally rigorous. The pool of talent available for adjunct instruction is
large and includes individuals engaged in regulatory affairs work in companies. Adjunct instructors will be required to have a
bachelors’ degree or higher in an appropriate discipline and demonstrate significant experience in regulatory affairs. They
will also be required to demonstrate teaching ability.
Dr. Ethan Sproat, a faculty member in the UVU Department of English and Literature, has been working closely with
industry experts to design a 5000-level Technical Communication course. Dr. Sproat recently earned a Ph.D. in English
Rhetoric and Composition from Purdue University with one of his emphases in Technical Communication. In addition to his
Ph.D. training, Dr. Sproat has significant professional experience in technical communication in the areas of professional
communication, copyediting, indexing, digital content development, small press publication, and digital audio/video
production management.
Staff
Administrative: The Director of the program will provide administrative assistance as well as have access to administrative
support in the Biology Department.
Secretarial: No secretarial staff will be required.
Updated 12/20/2013
Clerical: No clerical staff will be required.
Laboratory: This program does not have a laboratory component, thus no laboratory staff will be required.
Advisors: The College of Science and Health advisory staff will help to support the program.
Teaching/Graduate assistants: There will be no teaching or graduate assistant staff required.
Library and Information Resources
Library collections for the Regulatory Affairs Graduate Certificate program are difficult to define in specific numbers but can
be demonstrated in the following manner:
Journals:
UVU library uses broadcast or aggregator software (OneSearch) that searches our array of journal databases at one time.
For example, some typical OneSearch queries produce the following results, each hit limited to scholarly, full-text articles
with further refinement still possible:
“ISO 9001 and medical devices”
207
“medical devices and regulatory”
6402
“medical devices and design control”
9026
“medical devices and quality control”
8223
“pharmaceuticals and quality control”
5413
These articles are drawn from various journal databases including:
ABI/Inform (Business)
Applied Science and Technology Abstracts
Business Source Premier
CINAHL Nursing
Directory of Open Access Journals (DOAJ)
EconLit
Health Source: Academic
Legal Collection
Lexis/Nexis Academic
MEDLINE
PsychINFO
Science Direct
Representative journals would include:
American Journal of Life Sciences
British Journal of Pharmaceutical Research
Clinical Research and Regulatory Affairs
European Journal of Medicinal Chemistry
International Medical Device Regulatory Monitor
International Journal of Medical Marketing
Journal of the American Medical Association
Journal of Medical Diagnostic Methods
Journal of Medical Marketing
Journal of Medicinal Chemistry
Life Sciences
Medical Device Business Week
Medical Device Daily
Pharmaceutical Regulatory Affairs
Research in Pharmaceutical Sciences
Interlibrary Loan: Articles not found full-text in the databases may be requested electronically through Interlibrary Loan.
Patrons will be delivered an electronic version of the article in their email accounts within 2-4 working days.
Updated 12/20/2013
All databases are accessible from any point on the web using authentication.
Books:
Again, specific numbers are hard to determine but illustrative searches produce the following hits against the catalog:
“medical devices”
260
“medical devices and regulatory”
93
“medical devices and quality control”
9
“pharmaceuticals and quality control”
71
A large percentage of these titles are available from e-book packages and accessible from any web connection.
Through the Utah Academic Library Consortium, all student cards are valid at every public or private higher education
library in Utah.
Librarians are very accessible and are happy to give priority to faculty and graduate students for research support.
Requests for new materials that will support 5000-level and graduate programs are given high priority by the Library
Director.
Admission Requirements
The students must be admitted to the University based upon the following graduate admission requirements: 1) completion
of the university admissions application and submission of the following documents: official college transcripts from last
undergraduate institution attended, resume, and two letters of recommendation. Admission to the Regulatory Affairs for Life
Sciences certificate program will require a baccalaureate degree in a science or technology-related discipline.
Student Advisement
Prospective students will be advised of program matriculation and graduation requirements by the Biology Department
advisor. The Biology Department advisor will review the student’s career goals and programs in meeting the certificate
requirements upon completion of the first semester courses. Additionally, the program director will be available to discuss
the program and career goals with the students.
Justification for Graduation Standards and Number of Credits
Graduation standards are: (1) Completion of the required courses for the certificate at a minimum of 15 credit hours, (2) a
GPA of 3.2 or greater, and (3) Residency hours at a minimum of 12 credit hours through courses attended at UVU.
The credit hour requirement of 15 hours allows for incorporation of academically rigorous course content into the program
yet a reasonable number of hours for completion in one year or less. The required GPA is more than adequate to
demonstrate academic abilities and student potential for success in a graduate program. These courses are unique in their
content which was co-designed by university faculty members and industry partners.
External Review and Accreditation
External Review: The Regulatory Affairs for Life Sciences certificate program and its content have been reviewed and
validated by industry experts. The following individuals from industry provided guidance for curriculum material, content and
course sequencing, and matriculation and enrollment requirements: Peter Knauer, BioUtah; Karen Jones, Edwards Life
Sciences; Jeff Nelson, Nelson Labs; Balaji Suddabattula, Megadyne; Haven McCall, GE Medical; Jessica Smith, Bard
Access. The program Director from San Diego State University’s regulatory affairs program, Steven Dahms, was consulted
for advice on overall program design. There is no program-specific accreditation required by any regional or national
agency.
Updated 12/20/2013
Projected Program Enrollment and Graduates; Projected Departmental Faculty/Students
Data Category
Current – Prior to
New Program
Implementation
Projected
Projected
Projected
Projected
Projected
Year 1
Year 2
Year 3
Year 4
Year 5
X
0
10
12
12
12
15
15
15
15
34.00
34.00
34.00
34.00
Data for Proposed Program
Number of Graduates in Proposed
Program
Total # of Declared Majors in
X
12
Proposed Program
Departmental Data – For All Programs Within the Department
Total Department Faculty FTE (as
33.3
34.00
reported in Faculty table above)
Total Department Student FTE
(Based on Fall Third Week)
Student FTE per Faculty FTE (ratio
of Total Department Faculty FTE
and Total Department Student FTE
above)
Program accreditation-required
ratio of Student FTE/Faculty FTE,
if applicable: (Provide ratio
here:_______________________)
1175
1179.80
1181.00
1181.00
1181.00
1181.00
35.3
34.7
34.7
34.7
34.7
34.7
na
na
na
na
na
na
Expansion of Existing Program
This is not an expansion of an existing program.
Section III: Need
Program Need
There is a critical shortage of talent in regulatory sciences for Utah companies, and no program currently exists to address
this demand. Utah companies have indicated that their success and growth are being impacted negatively due to the lack of
available talent. Further, the ability to provide regulatory talent makes it easier to attract life science companies to Utah.
Students with baccalaureate degrees in chemistry, biotechnology, and especially biology will benefit from having a postbaccalaureate certificate that increases their employment options. The need for the program to be offered at the postbaccalaureate level was determined by life science companies (medical device, pharmaceutical, diagnostics,
biotechnology). Industry partners were adamant that employees in regulatory affairs needed a minimum of a baccalaureate
degree due to the nature of the work.
Labor Market Demand
This program, which benefits Utah’s Life Science companies (medical device, diagnostics, biotechnology, and
pharmaceutical), will address a significant unmet need. Utah Department of Workforce Services (DWS) Labor Market
Information (LMI) reports an average of 70 jobs posted annually for compliance and regulatory. These jobs are listed as
“five stars” which is an indicator of jobs with the strongest employment outlook and the highest wages. The growth of the
Life Science industry is supported by additional market data from DWS; specifically, in the second quarter of 2013, there
Updated 12/20/2013
were 439 Life Science businesses operating in Utah and more than $90 million in payroll for this same quarter 4. This data
indicates that the life science industry and its companies can be confident of continued growth.
Battelle generated a report for the Utah Cluster Acceleration Partnership (UCAP) program in August of 2012, which
demonstrated significant growth in demand for regulatory affairs professionals in the next five years. The report indicated
that there would be an annual projected growth of approximately 60-70 new hires in these regulatory positions. The UCAP
report independently confirmed through interviews with industry representatives that a current critical shortage of skilled
regulatory affairs professionals is adversely affecting their ability to develop and market their medical products.
A search conducted on several websites4 listed a total of 17-25 jobs posted for regulatory affairs positions in Utah. The
positions ranged from entry-level to managerial and all of them required a baccalaureate degree. The majority of the posted
positions were with life science companies; a few were associated with technical talent agencies and law firms.
It is important to note that the Utah life sciences industry continues to grow at approximately two percent annually, and it is
one of two Utah industries that did not experience a reduction or even flattening of job growth during the economic decline.
Further, it is anticipated that the increase in Federal Drug Administration (FDA) oversight of the natural products and dietary
supplement industry will result in a need for additional regulatory talent. This creates a compelling reason to create a new
certificate to help the life science industry meet current and project needs for its continued growth.
This program is being developed in direct response to industry demand, and with strong support from the Utah System of
Higher Education, the Governor’s Office of Economic Development, and Utah Department of Workforce Services. Industry
partners have indicated that they only hire individuals in regulatory affairs positions who already hold at least a
baccalaureate degree, hence the decision to create a graduate level certificate as an additional credential to a
baccalaureate degree. Further, all current regulatory affairs programs at other institutions of higher education are relatively
recent, and are at the graduate level, either as graduate certificates or master’s programs, with a small number of doctoral
programs. In consultation with industry experts, UVU has determined that the content of the graduate certificate described
here will meet the current needs for the vast majority of regulatory affairs positions in the State of Utah. As the discipline
continues to grow in demand and complexity, a master’s program may eventually be developed if and when it is warranted
by sufficient industry demand.
Student Demand
It is anticipated that student demand will come from recent graduates at UVU and other higher education institutions as well
as current employees in life science companies. Industry partners (e.g, Nelson Labs, Bard Access, Edwards Life Sciences,
Megadyne, BioFire) have committed to reimbursing tuition for employees that wish to enroll in the program.
As stated previously, funding was provided by the UCAP program to pilot several new courses in regulatory affairs. The new
courses for regulatory affairs were advertised for two weeks in the Fall 2013 semester. There were 24 inquiries into the
courses from prospective students (all were current employees in life science companies such as Nelson Labs, Bard
Access, and Edwards Life Sciences).
Student demand is projected to be high, especially for biology graduates. The certificate will add considerable value to an
existing baccalaureate degree. The employment opportunity will be high, job security will be strong, and there will be a
significant increase in wages for those with regulatory affairs skills. There were 90 biology graduates with a degree in 2012.
There are a total of 681 biology majors currently enrolled at UVU, with 349 of these students being seniors. Thus, there is a
4
Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)
Updated 12/20/2013
more than adequate pool of prospective students at UVU. It is expected that there will also be significant enrollment from
incumbent employees that are looking to expand their career opportunities.
Similar Programs
A benchmarking study was performed by the Utah Cluster Acceleration Partnership’s (UCAP) Life Sciences Talent
Committee to determine where and to what extent related programs exist in the other states. The study found 43 other
regulatory programs offered by institutions of higher education, none within the State of Utah. Of these programs, 22 offer
Master’s programs and 27 offer certificate programs. The College of Engineering at the University of Utah offers a course in
design control; however, it is specific for engineering majors. Faculty members from the College of Engineering have
indicated that it is not likely that engineering students would pursue jobs in regulatory affairs given the availability of other
career options.
Collaboration with and Impact on Other USHE Institutions
The initial work conducted on the design of the regulatory affairs courses and program was by the UCAP Talent Committee.
The UCAP Talent Committee is comprised of faculty members from the University of Utah (UU; College of Engineering),
Utah Valley University (UVU; College of Science and Health), and Salt Lake Community College (SLCC; Biomanufacturing
and Biotechnology). Industry members are represented by several Utah Life Science companies including Edwards Life
Sciences, Nelson Labs, Merit Medical, Becton Dickinson, and BioFire. There continues to be significant involvement from
the UofU and SLCC, as well as industry partners, in curriculum design and instruction.
The Dean for the College of Science and the Chair of the Biology Department at the University of Utah have expressed
interest in working with UVU to facilitate access to the certificate program for their students. The impact of the proposed
certificate program will be positive for other USHE institutions. The issue of providing biology graduates with post-graduation
options is important for all institutions. The collaborative nature of this project will facilitate access to the program by
students at all institutions.
Benefits
The certificate program evolved in response to a request from industry, through the UCAP process, to help meet a critical
demand for regulatory affairs talent. The ability to move quickly to create quality programs in response to industry demand
benefits UVU in several ways. It ensures that students have access to programs that provide ample job opportunities that
are accompanied by high wages. It also results in a productive relationship with local companies to build partnerships that
can help to sustain programs.
Consistency with Institutional Mission
A university should endeavor to meet student needs in the most marketable areas if it can reasonably do so, and should
create strong programs in fields that have a substantial impact upon the world as a whole. It is also critical that a university
play an integral role in the economy of the service area to support the growth of local companies. Finally, students should
be given options to maximize the value of their education. The proposed certificate will not only align with a critical industry
need, but also provide access to a certificate that can add value to a student’s education. A certificate in regulatory affairs
would fit the mission of UVU because it represents a program that is aligned with industry need and provides the education
necessary for students to have access to rewarding careers.
Section IV: Program and Student Assessment
Program Assessment
Assessment of student success will be monitored by the program director. Dr. McCall has academic and professional
experience that is specific to regulatory affairs, thus he is able to determine if the specific content of the program is of the
Updated 12/20/2013
quality needed for a graduate-level program in regulatory affairs. There are no national tests that allow for assessment of
UVU students in comparison to national data. Student performance (i.e., student and internship/capstone supervisor
satisfaction) in the required internship or capstone project will be tracked and assessed. The program director will track
post-graduation employment and monitor employer satisfaction with graduates.
Expected Standards of Performance
Students must earn a minimum of a 3.0 in all coursework to be recommended to an internship or capstone project. Students
will demonstrate an understanding of basic regulatory concepts (domestic and international), be able to analyze and
communicate regulatory issues and draft, and analyze and understand the submission process for regulatory affairs
documents.
Formative
Utah Valley University will be using Degree Works program to track individual students during the course of the certificate
program. The Biology Advisor, working with the program director, will consult with each student to assess success and
progress toward graduation. Adjunct instructors will be consulted on student performance when appropriate. Grades (a B or
higher) in pre-requisite courses will be considered as predictors of success in subsequent courses. Completion of required
courses with a B or higher will be demonstrative of success in the program. Students will be monitored in the courses to
determine satisfaction with instruction. Guest speakers will be evaluated for their ability to communicate a topic
appropriately and bring greater understanding of relevant topics to the students.
Summative
The successful completion of required courses, with a final target GPA of 3.0 or more, will be the culminating factor to define
student success. Placement into employment will be tracked and used to assess success of the student’s performance and
of the program. Questionnaires will be used to assess graduates’ perceptions about how well the program prepared them
for employment. The questionnaires will be completed six months post-employment.
Section V: Finance
Updated 12/20/2013
Department Budget
Departmental Data
Personnel Expense
Salaries & Wages
Benefits
Total Personnel Expense
Non-personnel Expense
Travel
Capital
Library
Current Expense
Total Non-personnel Expense
Total Expense
(Personnel + Current)
Departmental Funding
Appropriated Fund
Other:
Special Legislative
Appropriation
Grants and Contracts
Special Fees/Differential Tuition
Total Revenue
Difference
Revenue - Expense
Departmental Instructional
Cost/Student Credit Hour* (as
reported in institutional Cost Study
for “current” and using the same
Cost Study Definition for
“projected”)
Three-Year Budget Projection
Departmental Budget
Current
Year 1
Year 2
Departmental
Budget - Prior to Addition to
Total
Addition to
Total
New Program
Budget
Budget
Budget
Budget
$2,195,808
$869,828
$3,065,636
$14,500
$0
$0
$33,030
$47,530
$64,650 $2,260,458
$31,713
$901,541
$96,363 $3,161,999
$1,000
$2,500
$3,500
$15,500
$0
$0
$35,530
$51,030
Year 3
Addition to
Total
Budget
Budget
$2,586 $2,263,044
$1,269
$902,809
$3,855 $3,165,853
$0
$0
$0
$0
$0
$2,689 $2,265,733
$1,319
$904,129
$4,009 $3,169,862
$15,500
$0
$15,500
$35,530
$51,030
$0
$0
$35,530
$51,030
$3,113,166
$99,863 $3,213,029
$3,855 $3,216,883
$4,009 $3,220,892
$3,113,166
Year 1
$0 $3,113,166
Year 2
$3,717 $3,116,883
Year 3
$104,009 $3,220,892
$100,000
$3,113,166
$0
$88 na
$100,000
$100,000
$100,000 $3,213,166
$3,717 $3,216,883
$137
$137
$91 na
-$138
$0
$91 na
-$100,000
$0
$4,009 $3,220,892
$0
$0
$91
Funding Sources
The Utah Cluster Acceleration Partnership program (UCAP; administered by the Utah System of Higher Education) has
provided support for the first year of course design and implementation of pilot courses (July 1, 2013-June 30, 2014). A
second year of funding was secured from the UCAP oversight committee (July 1, 2014-June 30, 2015) to provide continued
support of the courses to allow for institutional support to be secured. The Utah DWS will administer the second year of
funding for the program.
Reallocation
No reallocation is needed.
Updated 12/20/2013
Impact on Existing Budgets
No impact expected.
Section VI: Program Curriculum
All Program Courses (with New Courses in Bold)
Course Prefix and Number
Title
B.S. degree in Biology, Biotechnology, or related
Matriculation Requirements
field.
Required Courses
BIOL 5000
Regulatory Affairs for Life Sciences
Quality Management Systems for the Life
BIOL 5010
Sciences
Design Control and Risk Management for the Life
BIOL 5020
Sciences
ENGL 5340
Technical Communication Theory and Practice
BIOL 580R or BIOL 581R
Capstone Project or Biology Internship
BIOL 579R
Special Topics
Total Number of Credits
Credit Hours
4.0
2.0
3.0
3.0
1.0
2.0
15.0
Program Schedule
Fall of First Year
(Course Prefix and Number)
BIOL 5000
ENGL 5340
BIOL 579R
Course Title
Credit
Hours
Regulatory Affairs for Life Sciences
4.0
Technical Communication Theory and Practice
3.0
Special Topics
2.0
Semester total:
Spring of First Year
(Course Prefix and Number)
BIOL 5010
BIOL 5020
BIOL 580R or BIOL 581R
Course Title
Credit
Hours
Quality Management Systems for the Life Sciences
Design Control and Risk Management for the Life Sciences
Capstone Project or Biology Internship
2.0
3.0
1.0
Semester total:
6.0
Section VII: Faculty
Director (Scholar-in-Residence/Faculty)
Updated 12/20/2013
9.0
A Director was recently hired to oversee the administration of the program, build partnerships that support the program, and
provide instruction. Dr. Haven McCall, the newly hired Director, exceeds the minimum qualifications and required
knowledge, skills, and abilities.
Dr. Haven McCall
Education
D.R.Sc., Regulatory Sciences, University of Southern California, Los Angeles
M.S., Regulatory Sciences, University of Southern California, Los Angeles
M.S., Business Management, Northern Arizona University
B.S./B.A., Business Management, Northern Arizona University
Work Experience
GE Healthcare, Regulatory/Quality Manager; 7/2009-2014
BD Medical, Senior Quality and Regulatory Systems Engineer; 7/2008-7/2009
Gore Scientific, Regulatory Affairs Leader; 5/2002-6/2008
Adjunct Faculty (teaching pilot course):
Dr. Vivian Ngan-Winward
Education
Ph.D. Molecular Biology and Biochemistry, Wesleyan University
B.S. Biology; University of British Columbia
Work Experience
Salt Lake Community College, Director of Biomanufacturing; 2/2008-current
BioFire (formerly Idaho Technology), Scientist II; 12/2002-1/2008
KKBiomed, Scientist; 1/2000-12/2002
ThauMDx, Research Manager; 8/2002-12/2002 (consulting)
Jennifer Bolander
Education
M.S., Quality Management, Eastern Michigan University
B.S., Biology, Northern Arizona University
Work Experience
BHI, Quality Manager; 2/2012-12/2013
NOV Intelliserv Inc., Quality Assurance Specialist; 04/2007-02/2012
USANA Health Sciences, Quality Assurance Specialist II; 03/2006-04/2007
Tandem Labs, Quality Assurance Compliance Specialist; 03/2004-12/2005
Baxter BioLife Plasma Services, Quality Management Representative; 10/2003-03/2004
Updated 12/20/2013