RGA 1010. U.S. Regulatory Systems and Agencies. (3 Hours)
Presents a comprehensive introduction to the U.S. regulatory environment for healthcare products. Explores the mission, history, and organization of the FDA and other federal agencies that regulate food, drugs, biologics, and devices. Traces the development of major U.S. laws (e.g., the Pure Food and Drug Act of 1906, the Food, Drug, and Cosmetic Act of 1938) and their amendments. Examines the end-to-end product approval process from nonclinical testing and clinical trials through regulatory submissions and postapproval requirements.
RGA 1050. Regulatory Policy Development. (3 Hours)
Presents a comprehensive survey of U.S. regulatory policy from the Progressive Era to the present. Examines how and why the U.S. “administrative state” regulates markets and society and analyzes the major debates and controversies that have shaped regulatory design and reform. Topics include the economic and social rationales for regulation; the rise of independent regulatory agencies; landmark statutes (e.g., Clean Air, OSHA); and modern case studies (e.g., antitrust, environment, food safety, energy, etc.). Emphasizes a policy-analysis perspective. .
RGA 1080. Pharmaceutical Regulatory Affairs. (3 Hours)
Introduces global regulatory affairs for pharmaceuticals. Covers the roles of major regulatory agencies that ensure drug efficacy, safety, and quality. Studies the drug approval process from early development through marketing authorization in various markets. Surveys marketing authorization procedures in the United States, European Union, United Kingdom, Japan, Australia, India, and selected emerging markets, as well as international harmonization guidelines that facilitate global submissions.
RGA 3000. Introduction to Safety Science. (3 Hours)
Introduces safety science as a multidisciplinary, evidence-based field focused on achieving productive well‑being while preventing harm in work and travel. Examines safety science from three complementary perspectives: individual (psychology), organizational (sociology), and systems. Explores how risk, human error, design, organizational reliability, and system dynamics interact to shape safety outcomes.
RGA 3300. Strategic Planning and Project Management for Regulatory Affairs. (3 Hours)
Introduces the biomedical product development process with a focus on strategic planning and project management. Examines each phase of drug development and the project manager’s role in coordinating cross-functional teams. Topics include key deliverables and timelines, portfolio and project management office structures, Agile methodologies, and regulatory submission strategies.
RGA 6105. Introduction to Regulatory Compliance and Practice. (3 Hours)
Presents a detailed overview of critical scientific, technical, engineering design, manufacturing, and operational drivers for regulatory compliance. Offers students an opportunity to gain competencies in the areas of regulatory agency, advocacy, ethics, mitigation laws, and corporate compliance responsibility. Studies the various state, federal, and international agencies; their authorities; and how they became established to enable students to understand the scientific and technical scope of the global regulatory compliance landscape.
RGA 6150. Regulatory Strategy for Product Development and Life-Cycle Management. (3 Hours)
Studies the preparation of regulatory strategies to support product development and life-cycle management. Examines domestic and international processes relevant to regulatory strategy. In developing target product profiles, strategic regulatory plans, and life-cycle management plans, offers students an opportunity to learn how to appraise key components of regulatory strategies, evaluate core elements of product life cycle in the generation of those strategies, and integrate business needs into regulatory planning.
RGA 6208. Introduction to Safety Sciences. (3 Hours)
Introduces safety and surveillance/pharmacovigilance regulations and principles for drugs, biologics, and medical devices across the therapeutic product life cycle. Studies safety/pharmacovigilance-related regulations and guidance from the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory authorities, as well as the role of multidisciplinary, global organizations in developing and harmonizing safety-related best practices. Studies adoption of a life-cycle perspective, beginning with the design of preclinical safety studies and their application to the design of clinical studies, continuing through clinical development and postmarketing. Examines safety and pharmacovigilance in the context of stand-alone and combination therapeutic products, the incorporation of safety information in regulatory documentation, safety data analysis, safety-related quality management, corrective and preventive actions, and regional and global safety initiatives.
RGA 6238. Human Experimentation Methodological Issues Fundamentals. (3 Hours)
Explores issues related to human experimentation, including methodological issues and the ethical, clinical, and financial repercussions of clinical trial studies. Covers how effective study designs can mitigate the common limitations and problems of clinical trials. Considers ethical issues, such as selective reporting of clinical research, informed consent, and protection of research participants in domestic and international clinical trials.
RGA 6285. Validation and Auditing of Clinical Trial Information. (3 Hours)
Presents a comprehensive overview of the management of quality assurance in clinical trials including Good Clinical Practice, clinical trial monitoring, clinical trial auditing, and management of audit outcomes, as well as current issues and trends in the validation and auditing of clinical studies.
Prerequisite(s): (RGA 6610 with a minimum grade of C- or RGA 6600 with a minimum grade of C- ) or BTC 6210 with a minimum grade of C- ; (RGA 6000 with a minimum grade of C- or RGA 6001 with a minimum grade of C- )
RGA 6290. Clinical Trial Design Optimization and Problem Solving. (3 Hours)
Discusses quantitative data analysis in creating dynamic drug-disease models, strategic market models, trial simulation models, and integrated financial models, which enable key variable analysis in clinical trial developments in real time. This integrated approach allows decisions in the design to optimize value against both scientific and business criteria simultaneously and continuously. Examines how to take a complete view of the development process at the outset and at all levels in the organization.
Prerequisite(s): RGA 6238 with a minimum grade of C- ; (RGA 6610 with a minimum grade of C- or RGA 6600 with a minimum grade of C- ) or (BTC 6210 with a minimum grade of C- ; RGA 6000 with a minimum grade of C- ) or RGA 6001 with a minimum grade of C-
RGA 6295. Managing International Clinical Trials. (3 Hours)
Focuses on initiating, collecting, and managing data from multicountry clinical trials and documenting the growing internationalization of clinical research in biomedicine. Focuses on trials carried out under the aegis of the U.S. Food and Drug Administration and investigators in the European Union, China, India, Africa, or Latin America regions. Studies the steps needed to conduct regulatory-compliant international trials using case studies and group projects.
Prerequisite(s): RGA 6238 with a minimum grade of C- ; (RGA 6610 with a minimum grade of C- or RGA 6600 with a minimum grade of C- ) or BTC 6210 with a minimum grade of C-
RGA 6308. Pharmaceutical and Medical Device Law: Topics and Cases. (3 Hours)
Analyzes current food, drug, and medical device laws. Reviews legislation and landmark cases—as well as laws governing development, manufacture, and commercial distribution of drugs, biologics, and medical device products—and how they relate to the biotechnology, pharmaceutical, and medical device industries.
Prerequisite(s): (RGA 6105 with a minimum grade of C- ; RGA 6150 with a minimum grade of C- ) or (RGA 6101 (may be taken concurrently) with a minimum grade of C- or RGA 6202 (may be taken concurrently) with a minimum grade of C- )
RGA 6350. Legal Issues in International Food, Drug, and Medical Device Regulation. (3 Hours)
Analyzes international laws related to the regulation of food, drugs, and medical devices, focusing on the European Union and Canada. Draws comparisons between international laws and corresponding U.S. laws as well as considerations necessary for international biotechnology, pharmaceutical, and medical device industries.
Prerequisite(s): (RGA 6002 with a minimum grade of C- ; RGA 6463 with a minimum grade of C- ) or (RGA 6105 with a minimum grade of C- ; RGA 6150 with a minimum grade of C- )
RGA 6400. Medical Device Product Development and Process Validation. (2 Hours)
Explores essential concepts, methodologies, and regulatory frameworks associated with validating manufacturing processes in the medical device industry. Focuses on a holistic understanding of these processes, methodologies, and regulations. Offers students an opportunity to gain the expertise needed to contribute effectively to producing safe, high-quality medical devices, while ensuring regulatory compliance, by delving into industry best practices, regulatory requirements, and risk-based strategies.
Prerequisite(s): ((RGA 6000 with a minimum grade of C- or RGA 6001 with a minimum grade of C- ); RGA 6002 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6415. Fundamentals of CMC Regulations and Methods. (2 Hours)
Discusses components of Common Technical Document Module 3 and describes how regulatory affairs professionals support compliance with chemistry, manufacturing, and controls (CMC) regulation. CMC regulatory affairs professionals must use technical, analytical expertise and problem-solving abilities to ensure only quality product is distributed to patients. Coursework consists of designing and evaluating core elements of an effective CMC compliance strategy, ensuring alignment with International Conference on Harmonization guidelines, U.S. Food and Drug Administration guidance, pharmacopeia, and 21 CFR.
Prerequisite(s): (RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6435. Medical Device Cybersecurity and Digital Health. (2 Hours)
Examines regulatory strategies to support software and cybersecurity product development and life-cycle management. Coursework consists of team-based projects focusing on a digital health product. Offers students an opportunity to explore product development of software and process development of cybersecurity while examining domestic and international processes relevant to software cybersecurity regulatory strategy.
Prerequisite(s): (RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6440. Advanced Topics in Advertising and Promotion of Drugs and Medical Devices. (2 Hours)
Analyzes the regulatory and legal guidelines and standards applicable to the promotion of drug and medical device products in the U.S. market. Includes regulations and policies of the Food and Drug Administration, Federal Trade Commission, Drug Enforcement Administration, Public Health Service, and the Office of the Inspector General, as well as professional guidelines of relevant organizations including AdvaMed, the Accreditation Council for Continuing Medical Education, the American College of Physicians, the Pharmaceutical Research and Manufacturers of America, and the American Medical Association. Explores marketing issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including continuing medical education, advertising of compounding products, off-label promotion, gifts to physicians, and direct-to-consumer advertising. Uses case studies to illustrate and discuss subjects of interest.
Prerequisite(s): (RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6450. Financing and Reimbursement in Biomedical Product Development. (2 Hours)
Introduces the complex discipline of global reimbursement and pricing strategy for medical devices, drugs, and biologic products. As cost and relative efficacy drivers become increasingly crucial to marketing biomedical products successfully, life-sciences regulatory professionals must evaluate regulatory compliance criteria concerning reimbursement and product pricing concerns. Regulatory professionals must also demonstrate that utilization of new biomedical products is comparatively cost-effective when measured against standards of clinical care. Using specific case studies from the United States and abroad, offers students an opportunity to analyze these market developments and their resulting implications for biomedical product development, manufacturing, and commercialization, with an overall objective to develop comparatively and financially informed regulatory systems.
Prerequisite(s): (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6465. Nonclinical Regulations in Biomedical Product Commercialization. (2 Hours)
Examines the nonclinical regulatory processes involved in commercializing biomedical products within the U.S. Food and Drug Administration's CBER, CDER, and CDRH. Offers students an opportunity to conduct a comprehensive analysis of FDA's quality standards for biomedical products, including gene and cellular-based therapies, with respect to ICH Common Technical Document Module 4. Presents an overview of preclinical investigational new drug requirements and good manufacturing practice regulations that must be fulfilled by biomedical product manufacturers in support of CTD Module 3. Studies biocompatibility testing requirements for medical devices according to FDA guidance and ISO 10993 standards to support 510(k) and PMA submissions.
Prerequisite(s): (RGA 6002 with a minimum grade of C- ; RGA 6463 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6475. Strategic Planning and Project Management for Regulatory Affairs. (2 Hours)
Introduces the core concepts of strategic planning and project management. Seeks to equip regulatory professionals with the skills needed to join upper corporate management in choosing which products to pursue and how best to pursue them. Offers students an opportunity to learn how to guide medical device teams through the design and development stages. Emphasizes the role of product classifications in demonstrating the safety, efficacy, and performance of medical devices for human use. Studies the function and format of presubmission meetings with U.S. and other global regulatory agencies, as well as their role in gaining regulatory approval for market sale.
Prerequisite(s): (RGA 6202 with a minimum grade of C- or RGA 6101 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6480. Real-World Evidence and Patient-Reported Outcomes in Regulatory Decision Making. (2 Hours)
Presents an overview of real-world evidence, discusses challenges in implementing an effective RWE strategy, and reviews the implications of RWE on regulatory decision making. Topics include patient-reported outcomes, observational studies/pragmatic clinical trials, comparative effectiveness research, registries, primary vs. secondary data collection, medical claims and electronic health record data, social media, wearable devices, and artificial intelligence.
Prerequisite(s): (BTC 6210 with a minimum grade of C ; (RGA 6000 with a minimum grade of C or RGA 6101 with a minimum grade of C )) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6490. Emerging Trends and Challenges in Regulatory Affairs. (2 Hours)
Examines the development and commercialization pathways for several emerging categories of drug and biologic products that are not formally classified by the U.S. Food and Drug Administration, including new OTC products, neutraceuticals, nanotechnology products, and precision medicine-based therapies. Evaluates the reasons why regulatory paradigms for these products are not well established and analyzes how the relatively amorphous nature of these paradigms has impacted commercialization of these product categories in the U.S. market. Offers students an opportunity to gain a better understanding of how and why new product categories continue to emerge as existing regulatory classifications continue to evolve.
Prerequisite(s): RGA 6202 with a minimum grade of C- or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6500. Biomedical Product Development: Regulatory Affairs in a Market-Based Setting. (2 Hours)
Examines the evolution and product development process of drug, diagnostic, and medical device industries from technological, regulatory, legal, and commercial perspectives, as well as from a societal and cultural framework. Also examines the symbiotic and potentially synergistic relationship that has developed between biotechnology, pharmaceutical, and medical device companies, as well as the impact of these relationships on the overall environment.
Prerequisite(s): (RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C- ) or (RGA 6208 with a minimum grade of C- ; RGA 6238 with a minimum grade of C- )
RGA 6600. Introduction to Food and Drug Administration Pharmaceutical Regulation. (3 Hours)
Presents an overview of current U.S. biopharmaceutical statutes and regulations. Offers students an opportunity to develop a strong understanding of biopharmaceutical regulatory affairs. Topics include the historical development of U.S. biopharmaceutical regulation, as well as an overview of biopharmaceutical product and clinical development, and applicable U.S. Food and Drug Administration approval processes. Also discusses the potential postmarket approval regulations for biopharmaceutical processes.
RGA 6610. Introduction to Food and Drug Administration Medical Device Regulation. (3 Hours)
Presents an overview of the medical device engineering, development, and commercialization process and its regulation by the U.S. Food and Drug Administration. Studies medical device regulatory affairs from a U.S.-centric perspective. Reviews the historical development of significant U.S. medical device legislation, including the Medical Device Amendments of 1976. Introduces quality management system regulation as it relates to medical device development in the United States.
RGA 6620. Medical Device Development: A Regulatory Overview. (3 Hours)
Analyzes and studies how to apply U.S. medical device development, clearance, and/or approval requirements. Examines quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act, in addition to providing a step-by-step guide through the Center for Devices and Radiological Health. Covers CDRH’s reengineering initiatives and evolving investigational device exemptions, premarket approval, 510(k) application process, and product development protocol and review processes. Provides practical, in-depth analyses on how emerging developments and trends are reshaping medical device regulation in the United States. Discusses the subjective and interpretive aspects of the regulations. Guides students how to think critically about the interaction between statutory, regulatory, and development processes.
Prerequisite(s): RGA 6610 with a minimum grade of C- or (BTC 6210 with a minimum grade of C- ; RGA 6001 with a minimum grade of C- )
RGA 6630. Medical Device Quality Management System: Principles and Applications. (3 Hours)
Introduces the U.S. Food and Drug Administration’s Quality Management System Regulation and describes how it can improve the safety and efficacy of medical devices. Discusses the legislative origins of the QMSR, its historical evolution from the Quality System Regulation to FDA’s harmonization of the U.S. Current Good Manufacturing Practice regulations with global quality management requirements, as well as the details of how QMSR is implemented. Examines case studies and real-world examples of applications of quality management system requirements by medical device manufacturers during the product commercialization process. Studies regulatory expectations for product design control and the structuring of QMSR documentation. Encourages students to develop strategies for customizing QMSR to particular companies, products, and manufacturing environments.
Prerequisite(s): RGA 6610 with a minimum grade of C- or (RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C- )
RGA 6640. Risk Management: Compliance and Processes. (3 Hours)
Examines risk management practices and their impact on patient safety, product quality, and clinical effectiveness. Discussions include analysis of medical device risk management guidance documents, how medical device companies strive to ensure compliance, the responsibilities of regulatory professionals in risk management systems, and regulatory issues stemming from poor supplier performance and management. Evaluates risk management systems as they relate to particular categories of biomedical products manufactured in specific contexts, using case-based investigations and real-world examples. Offers students an opportunity to obtain the skills and knowledge they need to customize effective risk management methods within various global settings.
Prerequisite(s): RGA 6610 with a minimum grade of C- or RGA 6000 with a minimum grade of C- or RGA 6001 with a minimum grade of C-
RGA 6650. Medical Device Product Development in Canada. (3 Hours)
Explores the requirements for medical device regulation in Canada and globally. Studies Canadian medical device regulations, including establishment licensing and compliance, device licensing, classification, significant change and license amendments, postmarket surveillance, and investigational testing requirements. Explores the use of global standards related to the regulation of medical devices.Familiarizes students with the International Medical Device Regulators Forum’s goals and objectives and explores its medical device regulatory model in use in many countries today.Covers the application of quality management principles to medical device development.Offers students a project-based opportunity to learn how to prepare a sample submission for Canada.
Prerequisite(s): (RGA 6001 with a minimum grade of C- or RGA 6202 with a minimum grade of C- ) or (RGA 6105 with a minimum grade of C- ; RGA 6150 with a minimum grade of C- )
RGA 6660. Therapeutic Product Development: A Regulatory Overview. (3 Hours)
Examines every step of the therapeutic development and regulation process within the Center for Biologic Evaluation and Research and Center for Drug Evaluation and Research, from preclinical testing through postmarketing adverse experience reporting. Offers students an opportunity to conduct a comprehensive and up-to-date analysis of the complete U.S. pharmaceutical and biological products approval processes. Considers U.S. Food and Drug Administration standards for nonclinical testing/quality assurance issues and good laboratory practice, investigational new drug applications, and therapeutic market applications. Reviews process initiatives designed to speed therapeutic product review, as well as current good manufacturing practice regulations to assure quality of marketed products. Also discusses regulation of generics, biosimilars, and orphan drugs.
Prerequisite(s): RGA 6600 with a minimum grade of C- or (RGA 6000 with a minimum grade of C- ; BTC 6210 with a minimum grade of C- )
RGA 6670. Global Impact of Electronic Common Technical Document (eCTD) Submissions. (3 Hours)
Examines the structure of the Common Technical Document format documents through the study of both regulatory requirements and example submissions. Offers students an opportunity to develop an understanding of the FDA's geographically specific eCTD submission requirements. Reviews the basic structure and format of an eCTD submission and the differences between the electronic format and former paper-based CTD submissions.
Prerequisite(s): RGA 6600 with a minimum grade of C- or (RGA 6101 with a minimum grade of C- ; BTC 6210 with a minimum grade of C- )
RGA 6675. Therapeutic Product Development in Canada. (3 Hours)
Focuses on Canadian legislation and regulations applicable to bringing therapeutic products to the Canadian market. Covers pharmaceuticals, biologics, generic drugs, and biosimilars. Examines each step of therapeutic drug development from preclinical testing to regulatory approval and postmarketing requirements. Studies relevant sections of the Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, and various policies, as well as how regulatory affairs professionals can add value to organizations. Presents dedicated study of clinical trial applications and new drug submissions, as well as compliance activities.
Prerequisite(s): (RGA 6105 with a minimum grade of C- ; RGA 6150 with a minimum grade of C- ) or RGA 6002 with a minimum grade of C-
RGA 6680. Project Management in Early Drug Discovery and Development. (3 Hours)
Highlights the applicability and utility of project management tools to the biopharmaceutical development process. Presents an overview of the processes common to researching and developing a new biopharmaceutical product. Focuses on the early stages of this progression, from identifying active molecules to completing Phase 1 safety trials. Surveys the predominant biological and chemical techniques used in these efforts. Offers students an opportunity to prepare standard operating procedures and a pre–Investigational New Drug package. Emphasizes how to incorporate key data in writing the IND. Examines the procedures used to execute a Phase 1 safety study and the strategies available to prepare a persuasive clinical study report.
Prerequisite(s): RGA 6600 with a minimum grade of C- or RGA 6101 with a minimum grade of C- or RGA 6202 with a minimum grade of C-
RGA 6685. European Medical Device Regulations. (3 Hours)
Covers European Commission directives and guidance documents; European Agency for the Evaluation of Medicinal Products, medical device guidance documents, and notified body guidelines and recommendations; Global Harmonization Task Force final reports; and mutual recognition agreements. Topics include biological and biotechnological products, Conformité Européenne marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization.
Prerequisite(s): (RGA 6203 with a minimum grade of C- or RGA 6204 with a minimum grade of C- ) or (RGA 6105 with a minimum grade of C- ; RGA 6150 with a minimum grade of C- )
RGA 6690. Global In Vitro Diagnostic Regulations and Submissions. (3 Hours)
Examines in-depth the regulations governing in vitro diagnostic medical devices. Studies the IVD regulations for the four major economic markets—United States, European Union, Australia, and Canada—as well as other markets that have specific IVD regulations, possibly including China, Brazil, and Mexico. Topics include IVD classification schemes, regulatory strategy, regulatory submission routes (including harmonization), regulatory review processes, performance evaluation, clinical trial requirements, labeling, and postmarketing. Also explores IVD testing methodologies and emerging trends in IVDs.
Prerequisite(s): RGA 6202 with a minimum grade of C- or RGA 6650 with a minimum grade of C-
RGA 6962. Elective. (1-4 Hours)
Offers elective credit for courses taken at other academic institutions. May be repeated without limit.
RGA 6980. Capstone: Practical Applications in Global Regulatory Affairs. (3 Hours)
Offers practice utilizing practical and application-oriented exercises and discussions designed to translate global regulatory requirements for pharmaceutical, biologic, and medical device product commercialization into submission-ready documents and broadly applicable regulatory science solutions. Topics covered include creating submission-quality documents based on relevant statutes, regulations, and guidelines; completing medical device and biopharmaceutical product development Good Laboratory Practice documentation; conducting product testing; performing inspections; and effective utilization of GxP requirements. Summarizes the curricular content of the MS Regulatory Affairs program. Coursework consists of group and individual projects and research applicable to regulatory and industry information, as well as activities designed to aid in comprehending global regulatory issues.
Prerequisite(s): RGA 6238 with a minimum grade of C- ; (RGA 6308 with a minimum grade of C- or RGA 6350 with a minimum grade of C- )
RGA 7100. Regulatory Frameworks for Biomedical Product Development. (3 Hours)
Offers students an opportunity to develop perspectives on strategic activities for the pre-commercialization of life science products in the United States. Focuses on stakeholder trends in the formulation and implementation of successful pre-commercialization regulatory strategies and submissions. Explores regulatory activities, including GLP requirements for the development of drug and biologic products and QSR requirements for the development of medical device design. Discusses the emerging paradigm of convergence between regulatory and reimbursement requirements, as well as life science product cost-effectiveness and health technology assessments. Incorporates case study analyses to evaluate the importance of including the most recent market access variables into the formulation of regulatory strategies.
RGA 7110. Biomedical Product Post-Market Regulatory Strategy. (3 Hours)
Offers students an opportunity to develop perspectives on life science product post-commercialization strategic activities in the U.S. market. Focuses on key stakeholder trends in the formulation and implementation of successful post-commercialization regulatory strategies and submissions. Explores the development of post-market surveillance strategies, adverse event reporting requirements, and regulatory strategies to monitor manufacturing of commercialized pharmaceutical, biologic, and medical device products. Reviews the evolving nature of advertising and promotional regulation given the rapid advance in social media technologies.
RGA 7120. Multi-Stakeholder Perspectives in Biomedical Product Access. (3 Hours)
Offers students an opportunity to develop life science product commercialization strategies from the regulator’s perspective. Explores regulatory affairs topics including preclinical and clinical safety and performance data, labeling requirements, potential long-term product effects, and manufacturing considerations. Through critical analysis of pre- and post-commercialization regulatory submissions, synthesizes the effectiveness of safety and efficacy measures to warrant approval. Considers the role of the regulator in evaluating technological advancements in personalized medicine, companion diagnostics, combination products, and other emerging product categories.
RGA 7130. Research Methodologies in Regulatory Affairs. (3 Hours)
Explores the significance of regulatory science as an emerging yet critical data-driven discipline exemplified by recent FDA initiatives to codify and document its development. Offers students an opportunity to develop expertise in methodologies to evaluate the effectiveness of regulatory strategies. Analyzes methodologies from both retrospective and prospective vantage points. Assesses the impact of user fees, new guidance documents, and evolving regulatory paradigms for the commercialization of pharmaceutical, biologic, and medical device products. Supports development of doctoral dissertation ideas through the application of research methodologies.
RGA 7962. Elective. (1-4 Hours)
Offers elective credit for courses taken at other academic institutions.
RGA 7983. Topics. (1-4 Hours)
Covers special topics in regulatory affairs. May be repeated four times for a maximum of 20 semester hours.