Biomedical Regulatory Affairs
The Biomedical Regulatory Affairs Concentration of the Master of Science in Leadership program will empower students with in-depth knowledge, technical and business skills necessary to address FDA-imposed regulation issues throughout the lifecycle of emerging medical products.
- Students will understand the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field.
- Students will learn how to locate regulatory information in key national and international sources.
- Students will apply the laws and regulations that govern the development, testing, and production of medical products, including biotechnology-derived therapeutics and medical devices.
- Students will explore product development, manufacturing, post-marketing requirements, reporting and enforcement.
Who Should Pursue This Concentration?
- Individuals who seek to expand their understanding of regulatory affairs for the drug and medical device industry
- Individuals who want to enter or advance in the biomedical regulatory affairs field, including designers, supervisors, engineers, R&D managers, HR managers.
Career Impact of This Concentration
Biomedical Regulatory Affairs builds knowledge and skills necessary to provide leadership and oversight of effective regulatory affairs and compliance. Trine University has recently (June, 2010) become a partner in the OrthoWorx initiative, which is a Warsaw, Indiana based industry, community, and education initiative to support growth and innovation in the region’s orthopedics device sector. The “biomedical corridor” with its hub in Warsaw that radiates throughout Northeast Indiana is the largest in the world, hosting 3 of the 5 leading orthopedic device companies. According to the Indiana Health Industry Forum (2008), a total of 84 companies that support biomedical and life sciences exist in this region, all of which must demonstrate internal and external regulatory compliance:
- 9 research and development firms that primarily serve the orthopedic industry,
- 16 manufacturers of orthopedic devices,
- 12 third-tier engineering firms,
- 6 firms that manufacture electro medical apparatuses,
- 15 firms that make surgical and medical equipment,
- 5 manufacturers of surgical appliances,
- 13 firms that make dental equipment, and
- 8 that manufacture hospital equipment and supplies.
According to a Lilly Endowment-funded needs assessment (BioCrossroads, 2009) that established the necessity of OrthoWorx as a coordinating body for education and workforce development, three specific needs were identified that will be met through the delivery of this concentration. First, federal regulatory and compliance scrutiny of the medical device industry has increased tremendously. Second, across the orthopedics device workforce, significant education and training shortfalls have led to a shortage of qualified workers. Third, the industry finds it difficult to attract and retain senior engineering and management talent.
Trine University has proposed, and has been welcomed by the members of OrthoWorx to meet these needs by delivering the Biomedical Regulatory Affairs concentration as both a part of the MSLDR program for individuals charged with leading departments in these companies and a stand-alone certificate program for designers, engineers, and others in the workforce who hold a bachelor’s degree and desire only the content-area expertise. These two educational opportunities will equip workers with the capacity to effectively address regulatory issues. Students who complete this concentration area will be equipped to pursue the Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification for U.S. companies (RAC-US) through an examination, which, when passed, will provide a nationally-recognized credential in regulatory affairs (RAPS, 2010).
Concentration Coursework (15 Credit Hours)
LDR 6103 Introduction to Biomedical Regulatory Affairs (3)
This course surveys government oversight of devices and biotechnology derived products; laws and regulations that apply to development, testing and production. It also addresses the responsibilities of a regulatory affairs specialist the regulatory setting.
LDR 6123 Product Development and Manufacturing Systems (3)
This course covers product development and manufacturing concerns such as quality control, scale-up, good manufacturing practices (GMPs) and quality systems), the U.S. Food and Drug Administration inspection process, and FDA regulatory actions. Focus on the QSIT (Quality System Inspection Technique).
LDR 6133 Qualitative Decision Making in Biomedical Regulatory Affairs (3)
A review of methods used to collect information to support business decisions, such as surveys, focus groups, competitive studies, and benchmarking. Topics include designing procedures to obtain unbiased data, scaling methods, and analysis and interpretation of data to produce credible results and recommendations. Emphasis is placed on intelligence necessary to support strategic planning activities and initiatives. Upon successful completion of this course, a student will be able to discern when to use qualitative techniques and the limitations of qualitative studies, design a study around research questions, choose appropriate samples from the population, and prepare the research instruments, prepare to conduct in-depth interviews and focus groups, analyze data and correlate results of qualitative studies.
LDR 6143 Product Testing, Evaluation, Clinical Trials, and Post-Market Issues (3)
This course focuses on post-marketing requirements, reporting and enforcement actions. Emphasis is on inspection (internal and by regulators) preparation, conduct and follow-up actions. It also introduces the major concepts under which clinical trials are designed and run, including the phases of clinical trials, study design and statistical concepts, the role of the U.S. Food and Drug Administration, Institutional Review Boards, the Code of Federal Regulations and ethical principles. Post-marketing surveillance and studies, and reimbursement and economics of biomedical interventions are discussed.
LDR 6163 Biomedical Regulatory Affairs Capstone (3)
This course provides a practical experience to ensure that participants can conceptualize the shepherding of new biomedical products through regulatory, clinical and quality assurance aspects. Students work on projects of their choice under the guidance of an adviser. The final report will consist of a comprehensive regulatory strategy work plan for a product, using knowledge gained in the concentration-area courses.