Cover/Signature Page – Full Template

Institution Submitting Request: Utah Valley UniversityProposed Title: Graduate Certificate in Regulatory Affairs for Life SciencesSchool or Division or Location: College of Science and HealthDepartment(s) or Area(s) Location: Department of BiologyRecommended Classification of Instructional Programs (CIP) Code1 30.0101Proposed Beginning Date: 08/01/2014Institutional Board of Trustees’ Approval Date: 02/13/2014Proposal Type (check all that apply):

Regents’ Agenda ItemsR401-4 and R401-5 Approval by Committee of the Whole

SECTION NO. ITEM4.1.1 (AAS) Associate of Applied Science Degree

4.1.2 (AA) Associate of Arts Degree(AS) Associate of Science Degree

4.1.3 Specialized Associate Degree4.1.4 Baccalaureate Degree4.1.5 K-12 School Personnel Programs4.1.6 Master’s Degree4.1.7 Doctoral Degree5.2.2 (CER C) Certificate of Completion5.2.3 x Graduate Certificate5.2.4 Fast Tracked Certificate

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 TemplateUtah Valley University

Graduate Certificate in Regulatory Affairs for Life Sciences12/20/2013

Program DescriptionThe 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 FitThe 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 DemandThe 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) 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

Updated 12/20/2013

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 DemandWhile 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 USHEA 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.

Program Description – Full TemplateUtah Valley University

Graduate Certificate in Regulatory Affairs for Life Sciences12/20/2013

Section I: The Request

2 Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)

Updated 12/20/2013

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 DescriptionThe 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 DegreeThe 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.

Institutional ReadinessThe 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

3

Updated 12/20/2013

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

Faculty Headcount – Prior

to Program Implementation

Faculty Additions to

Support Program

Faculty Headcount at Full

Program Implementation

With Doctoral Degrees (Including MFA and other terminal degrees, as specified by the institution)

Full-time Tenured 17 17 Full-time Non-Tenured 5 5 Part-time Tenured Part-time Non-Tenured 2 2With Master’s Degrees Full-time Tenured 0 0 Full-time Non-Tenured 0 1 1 Part-time Tenured 9 9 Part-time Non-Tenured 0 0With Baccalaureate Degrees Full-time Tenured 0 Full-time Non-Tenured 0 Part-time Tenured 0 Part-time Non-Tenured 13 13Other Full-time Tenured 0 0 Full-time Non-Tenured 0 Part-time Tenured 0 Part-time Non-Tenured 17 1 18Total Headcount Faculty Full-time Tenured 17 17 Full-time Non-Tenured 5 6 Part-time Tenured 9 9 Part-time Non-Tenured 32 33

Updated 12/20/2013

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.”)

38 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.

StaffAdministrative: 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.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 ResourcesLibrary 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

Updated 12/20/2013

“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) Health Source: AcademicApplied Science and Technology Abstracts Legal CollectionBusiness Source Premier Lexis/Nexis AcademicCINAHL Nursing MEDLINEDirectory of Open Access Journals (DOAJ) PsychINFOEconLit Science Direct

Representative journals would include:American Journal of Life SciencesBritish Journal of Pharmaceutical ResearchClinical Research and Regulatory AffairsEuropean Journal of Medicinal ChemistryInternational Medical Device Regulatory MonitorInternational Journal of Medical MarketingJournal of the American Medical AssociationJournal of Medical Diagnostic MethodsJournal of Medical MarketingJournal of Medicinal ChemistryLife SciencesMedical Device Business WeekMedical Device DailyPharmaceutical Regulatory AffairsResearch in Pharmaceutical SciencesInterlibrary 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.

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” 71A 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.

Updated 12/20/2013

Admission RequirementsThe 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 AdvisementProspective 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 CreditsGraduation 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 AccreditationExternal 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.

Projected Program Enrollment and Graduates; Projected Departmental Faculty/Students

Data CategoryCurrent – Prior to

New Program Implementation

Projected Projected Projected Projected Projected

Year 1 Year 2 Year 3 Year 4 Year 5

Data for Proposed ProgramNumber of Graduates in Proposed Program X 0 10 12 12 12

Total # of Declared Majors in Proposed Program X 12 15 15 15 15

Departmental Data – For All Programs Within the DepartmentTotal Department Faculty FTE (as reported in Faculty table above) 33.3 34.00 34.00 34.00 34.00 34.00

Total Department Student FTE (Based on Fall Third Week) 1175 1179.80 1181.00 1181.00 1181.00 1181.00

Student FTE per Faculty FTE (ratio of Total Department Faculty FTE and Total Department Student FTE above)

35.3 34.7 34.7 34.7 34.7 34.7

Updated 12/20/2013

Program accreditation-required ratio of Student FTE/Faculty FTE, if applicable: (Provide ratio here:_______________________)

na na na na na na

Expansion of Existing ProgramThis is not an expansion of an existing program.

Section III: Need

Program NeedThere 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 post-baccalaureate certificate that increases their employment options. The need for the program to be offered at the post-baccalaureate 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 DemandThis 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 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 4 Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)

Updated 12/20/2013

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 DemandIt 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 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 ProgramsA 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 InstitutionsThe 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.

Updated 12/20/2013

BenefitsThe 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 MissionA 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 AssessmentProgram AssessmentAssessment 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 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 PerformanceStudents 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.

FormativeUtah 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.

SummativeThe 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

Addition to Budget

Total Budget

Addition to Budget

Total Budget

Addition to Budget

Total Budget

Salaries & Wages $2,195,808 $64,650 $2,260,458 $2,586 $2,263,044 $2,689 $2,265,733Benefits $869,828 $31,713 $901,541 $1,269 $902,809 $1,319 $904,129Total Personnel Expense $3,065,636 $96,363 $3,161,999 $3,855 $3,165,853 $4,009 $3,169,862

Travel $14,500 $1,000 $15,500 $0 $15,500 $0 $15,500Capital $0 $0 $0Library $0 $0 $0Current Expense $33,030 $2,500 $35,530 $0 $35,530 $0 $35,530Total Non-personnel Expense $47,530 $3,500 $51,030 $0 $51,030 $0 $51,030

Total Expense (Personnel + Current)

Appropriated Fund $3,113,166 $0 $3,113,166 $3,717 $3,116,883 $104,009 $3,220,892Other:Special LegislativeAppropriationGrants and Contracts $100,000 $100,000 $100,000 -$100,000 $0Special Fees/Differential Tuition

Total Revenue $3,113,166 $100,000 $3,213,166 $3,717 $3,216,883 $4,009 $3,220,892

Revenue - Expense $0 $137 $137 -$138 $0 $0 $0Departmental Instructional Cost/Student Credit Hour* (as reported in institutional Cost Study for “current” and using the same Cost Study Definition for “projected”)

$88 na $91 na $91 na $91

Three-Year Budget Projection

Departmental Data

Current Departmental

Budget - Prior to New Program

Departmental BudgetYear 1 Year 2 Year 3

Personnel Expense

Non-personnel Expense

$3,113,166 $99,863 $3,213,029 $3,855 $3,216,883 $4,009 $3,220,892

Difference

Year 1 Year 2 Year 3Departmental Funding

Funding SourcesThe 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.

ReallocationNo reallocation is needed.

Updated 12/20/2013

Impact on Existing BudgetsNo impact expected.

Section VI: Program Curriculum

All Program Courses (with New Courses in Bold)Course Prefix and Number Title Credit Hours

Matriculation Requirements B.S. degree in Biology, Biotechnology, or related field.

Required CoursesBIOL 5000 Regulatory Affairs for Life Sciences 4.0

BIOL 5010 Quality Management Systems for the Life Sciences 2.0

BIOL 5020 Design Control and Risk Management for the Life Sciences 3.0

ENGL 5340 Technical Communication Theory and Practice 3.0BIOL 580R or BIOL 581R Capstone Project or Biology Internship 1.0BIOL 579R Special Topics 2.0

Total Number of Credits 15.0

Program Schedule

Fall of First Year(Course Prefix and Number)

Course Title CreditHours

BIOL 5000 Regulatory Affairs for Life Sciences 4.0

ENGL 5340 Technical Communication Theory and Practice 3.0

BIOL 579R Special Topics 2.0

Semester total: 9.0

Spring of First Year(Course Prefix and Number)

Course Title CreditHours

BIOL 5010 Quality Management Systems for the Life Sciences 2.0

BIOL 5020 Design Control and Risk Management for the Life Sciences 3.0

BIOL 580R or BIOL 581R Capstone Project or Biology Internship 1.0

Semester total: 6.0

Section VII: Faculty

Director (Scholar-in-Residence/Faculty) 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

Updated 12/20/2013

EducationD.R.Sc., Regulatory Sciences, University of Southern California, Los AngelesM.S., Regulatory Sciences, University of Southern California, Los Angeles M.S., Business Management, Northern Arizona UniversityB.S./B.A., Business Management, Northern Arizona University

Work ExperienceGE Healthcare, Regulatory/Quality Manager; 7/2009-2014BD Medical, Senior Quality and Regulatory Systems Engineer; 7/2008-7/2009Gore Scientific, Regulatory Affairs Leader; 5/2002-6/2008

Adjunct Faculty (teaching pilot course):

Dr. Vivian Ngan-WinwardEducation Ph.D. Molecular Biology and Biochemistry, Wesleyan UniversityB.S. Biology; University of British Columbia

Work ExperienceSalt Lake Community College, Director of Biomanufacturing; 2/2008-currentBioFire (formerly Idaho Technology), Scientist II; 12/2002-1/2008KKBiomed, Scientist; 1/2000-12/2002ThauMDx, Research Manager; 8/2002-12/2002 (consulting)

Jennifer BolanderEducationM.S., Quality Management, Eastern Michigan UniversityB.S., Biology, Northern Arizona University

Work ExperienceBHI, Quality Manager; 2/2012-12/2013NOV Intelliserv Inc., Quality Assurance Specialist; 04/2007-02/2012USANA Health Sciences, Quality Assurance Specialist II; 03/2006-04/2007Tandem Labs, Quality Assurance Compliance Specialist; 03/2004-12/2005Baxter BioLife Plasma Services, Quality Management Representative; 10/2003-03/2004

Updated 12/20/2013