Regulatory Affairs Certificates

The development and use of medical devices, pharmaceuticals, biologics, and combination products are highly regulated in the United States by the U.S. Food and Drug Administration and by regional regulatory agencies worldwide. Regulatory Affairs professionals are increasingly becoming an integral part of research, development, manufacturing, and marketing teams across the healthcare manufacturing sector, as well as academic and clinical research, and are employed in industry, government, and academia. Regulatory Science specialists are closely aligned with Regulatory Affairs and provide expertise in planning product safety and efficacy studies, monitoring investigations, and interpreting and reporting data. Regulatory Affairs and Regulatory Science professionals are instrumental throughout the entire lifecycle to the success of healthcare products.

For BME students, succeeding in the biomedical industry requires a thorough understanding of the biomedical regulatory landscape and practices and the ability to apply them in a realistic, practical environment. Demand in the biomedical and pharmaceutical industry for graduates with practical knowledge of regulatory affairs is growing.

The proposed regulatory affairs/regulatory science program will provide students with a solid foundation and skills in medical devices, drugs, biologics, and combination products regulations in the United States and major areas worldwide.

Undergraduate Certificate require completion of 20 CR in core and elective courses. Graduate Certificate require completion of 16 CR in core and elective courses.

Core courses

#		Course title	Course number	Content	U/G Cert	Prerequisites
1	Medical Devices and Combination Products Regulations		BME 5110	US combination products regulations. Within the BME RA MS program framework, this course is a part of the two-semester course sequence covering medical device and combination product regulations and submissions, with elements of Quality Assurance (Quality System Regulations, standards, etc.)	4	Major status, undergraduate status or instructor’s permission
2	Regulatory Affairs 2 – Introduction to the US and International Regulations		BME 5120	Biomedical Engineering, especially the development of drugs, biologics, medical devices, and combination products is highly regulated by US FDA and other regulatory agencies around the globe. Succeeding in the biomedical industry requires a good understanding of current regulations and the ability to apply them in a realistic, practical environment. There is a strong demand in industry for graduates with practical knowledge of regulatory affairs. This course is the 2nd of the Department of Bioengineering’s hands-on regulatory affairs curriculum and emphasizes EU and international regulatory requirements for medical products.	3	Major status, undergraduate status, or instructor’s permission
3	BME Research Thesis Writing and Communication, or equivalent		BME 4991	In conjunction with BME4992, this course fulfills the University’s upper-division writing requirements (CW). The instructional foci of this course are three-fold: research thesis writing, technical speaking, and poster development.		C or better in BME 4990, or instructor’s permission.
4	Applied Math and Statistics for Biomedical Engineers		BIOEN 3070 equivalent	Introduction to Statistics for Biomedical Engineers	3	C or better in BME 3301
5	Internship		Non-credit	In collaboration with RAPS and local medical device industry	1

 

Elective courses

1	bioDesign I – Design Control	BME 3801	Biomedical engineering design is covered from an FDA medical device design perspective. Topics include team building, literature searches, and project management. Discussions on economic, environmental, sustainability, manufacturability, ethical, health and safety, social, and political considerations will be included. Students will be assigned to groups to work on a design project that will continue into BIOEN 4801.	3	Prerequisites: C or better in (BME 3301 AND BME 3202) AND Full Major status in Biomedical Engineering. Co-requisites: C or better in BME 3070 OR ECE 3530 OR CS 3130.
2	bioDesign II	BME 4801	Continuation of BME 3801. Initial designs will be prototyped before going through a design review. Design validation issues and improvements will then be solved in a redesign phase following a design process based on FDA-QSR. Projects will be team oriented and lead to increased project management skills. In addition, discussions on design considerations will continue. A final written design document and an oral presentation of the working prototype will culminate the class. Lecture: 1 hour and Lab: 6 hours.	3	C or better in BME 3801
3	Clinical Research Methods and Practice I	PED 5900	This is a course offered through the University of Utah, Department of Pediatrics available to junior and senior level undergraduate and graduate students. The course involves 6-12 hours/week enrolling patients into clinical research studies and weekly class lectures pertaining to clinical research. Students who participate in this course have the opportunity to work in a clinical setting, gain exposure to clinical research, and develop relationships with Department of Pediatrics faculty. Students will receive 4 credit hours for 6 hours/week clinical work, 5 credit hours for 9 hours/week, or 6 credit hours for 12 hours/week.	3	Junior or Senior status
4	Clinical Research Methods and Practice II	PED 5901	This course will build off of research principles covered in PED 5900. Class content will be based on the given semester’s studies, as well as student interests. Students who participate in this course have an opportunity to work in a clinical setting, gain exposure to clinical research, and develop relationships with Department of Pediatrics faculty. The IRB Human Subject Research Training program will also be utilized in the course.	3	B- or better in PED 5900
5	IRBs	PED 5600	This course will work directly with the University of Utah Institutional Review Board. The students will have the opportunity to participate in the IRB monthly meetings and review assigned research projects. The students will also complete online RATS IRB courses, Human subjects training, Good Clinical Practices, and SIRB training. Through this course, students will be able to work closely with IRB procedures and gain real-world experience in reviewing research. Students may take this course up to two times for credit.	2	N/A

Students can pursue the Certificate in Regulatory Affairs in Healthcare and a graduate degree at the University of Utah in a related field (Biomedical Engineering, Pharmacy, Biology, Chemistry, Mechanical Engineering, Computer Science, Electrical or Computer Engineering, etc.) or as Non-matriculated students. Students interested in pursuing the Certificate in Regulatory Affairs in Healthcare and a related MS or PhD degree should apply via the University of Utah Graduate School application.

 

Students wishing to complete the certificate as Non-matriculated students should apply to the University of Utah as such (Non-matriculated students).

 

After admission to the University of Utah, students must complete a separate certificate application on the Regulatory Affairs program webpage. Students should have a STEM-related bachelor’s degree with at least a 3.0 GPA. GRE scores are not required for admission to the certificate program.

Program Requirements

Total Credits required for Certificate

16

Minimum Program Hours

16

Program Graduation Requirements

A minimum grade of B in the required and elective courses.

 

Core Courses

Complete ALL of the following Courses:

BME5110 – Regulatory Affairs

BME5120 – Regulatory Affairs II

LAW7080 – Special Topics (or equivalent)

MDCRC6000 – Introduction to Biostatistics (or equivalent)

 

Elective Courses

Earn at least 4 credits from the following:

BME6081 – Biomedical Device Innovation I

BME6082 – Biomedical Device Innovation II

MDCRC6040 – Design and Implementation of Clinical Trials

MDCRC6430 – Bioethical Issues in Clinical Research

MDCRC6470 – Implementation of Clinical Trials

PED5600 – Institutional Review Board – Student Volunteer

PED5900 – Clinical Research Methods and Practice I

PED5901 – Clinical Research Methods and Practice II

PBHLT6100 – Biostatistics I

PHARM6500 – Therapeutics Discovery, Development, and Evaluation