Regulatory Affairs - CPS (RGA)

RGA 0502. Principles and Practices of U.S. Regulatory Affairs. 2.5 Hours.

Offers students an opportunity to prepare for the RAC examination. Uses the “multiple heads” advantage theory by brainstorming with peers, asking questions of the experts, and discussing every aspect of the RAC exam in open forum format. Uses a self-scored practice exam to assess students’ understanding and preparation for the exam; all correct and incorrect answers are fully explained by the course instructors. Awards 2.5 CEUs on completion of the course.

RGA 0800. Global Regulatory Affairs Certificate Course. 0 Hours.

Offers health regulators and biomedical industry representatives an opportunity to learn the core elements of contemporary medical device regulations. Emphasizes a life-cycle approach to viewing biomedical product governance. Covers such topics as good clinical practices and ICH guidelines, common technical documents and submissions, medical device nomenclatures and classifications, good manufacturing practices and ISO standards, labeling requirements, marketing and advertising, and adverse event reporting and postmarket surveillance. Focuses both on the differences between national regulatory systems and on the efforts to harmonize device regulations through such organizations as the Global Harmonization Task Force.

RGA 5976. Directed Study. 1-4 Hours.

Offers independent work under the direction of members of the department on a chosen topic.

RGA 5978. Independent Study. 1-4 Hours.

Offers independent work under the direction of members of the department on a chosen topic.

RGA 5984. Research. 1-4 Hours.

Offers students an opportunity to conduct research under faculty supervision.

RGA 6100. Introduction to Drug and Medical Device Regulation. 4 Hours.

Provides an overview of drug, biologics, and device development and the FDA. Through course work and discussion, offers students an opportunity to gain the foundations necessary to build a strong understanding of regulatory affairs. Topics include the historical development of U.S. drug laws, law vs. regulation, FDA and industry functions, policy-guided science, and cases shaping history into the present state of regulation.

RGA 6110. Understanding the Healthcare Landscape. 4 Hours.

Explores the key actors, institutions, and policies that shape current healthcare and the biomedical regulatory environment. Focuses on the disparate and overlapping parties (e.g., patients, physicians, hospitals, insurers, nurses, Medicare, Medicaid, pharmaceutical, and medical device firms), their interests, and their interactions. Emphasizes the ways in which these relationships determine the quality, access, and the costs of healthcare. Through a careful reading of primary sources, offers students an opportunity to see the healthcare crisis from the perspective of different parties. Highlights the ways in which the healthcare landscape shapes the development, marketing, and regulation of drugs, biologics, and medical devices.

RGA 6112. Biomedical Intellectual Property Management: Patents. 4 Hours.

Emphasizes the practical uses and financial benefits of sound patent, licensing, and trademark practices. One of the primary functions of the biomedical industry is to produce intellectual property (IP) in the forms of drugs, biologics, and medical devices. To protect these resources, industry leaders must make prudent IP decisions at the beginning of any product development. Through a careful examination of case studies and through multiple group projects, offers students an opportunity to become familiar with the relevant legal issues (e.g., pertinent case law and statutes), the “how-to-gets” involving IP protection, and the strategies employed to license proprietary technology. Prereq. RGA 6200, RGA 6202, or RGA 6205. .

RGA 6200. Biologics Development: A Regulatory Overview. 4 Hours.

Offers students an opportunity to conduct a comprehensive and up-to-date analysis of the post-reform FDA Center for Biologics Evaluation and Research (CBER) and the complete U.S. biological product approval process, from preclinical testing to postmarketing regulatory requirements. Includes both CBER official and industry expert perspectives on quality assurance issues and related regulatory topics in successfully bringing biologics to market, as well as current good manufacturing practice regulations to assure quality of marketed products. Prereq. RGA 6201.

RGA 6201. New Drug Development: A Regulatory Overview. 4 Hours.

Examines every step of the drug development and regulation process, from preclinical testing through postmarketing adverse experience reporting. Considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug application (NDA) and review process initiatives designed to speed drug review, and the Prescription Drug User Fee Act (PDUFA).

RGA 6202. Medical Device Development: A Regulatory Overview. 4 Hours.

Analyzes U.S. medical device development and approval requirements. Features detailed analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA), in addition to providing a step-by-step guide through the Center for Devices and Radiological Health (CDRH). 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. Offers students an opportunity to demonstrate an appreciation of the subjective and interpretive aspects of the regulations and an ability to think critically about the interaction between regulatory and development processes. Prereq. RGA 6100.

RGA 6203. Food, Drug, and Medical Device Law: Topics and Cases. 5 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. Prereq. RGA 6200 or RGA 6202.

RGA 6205. Emerging Trends and Issues in the Medical Device Industry. 4 Hours.

Focuses on trends expected to have a significant effect on the future of the medical device industry, including the aging population; the need for devices that treat chronic illnesses such as renal failure, congestive heart failure, heart abnormalities, arthritis, and diabetes; reimbursement issues arising from the huge financial burden placed on Medicare and insurance companies in picking up the increased cost of healthcare; lifestyle changes with an increased demand for devices that improve one’s quality of life or appearance; reuse of single-use disposable devices to cut costs; group purchasing practices, outpatient treatment; telemedicine, regulatory/legal requirements; and the movement of devices into new areas, such as coating stents with pharmaceutical/biological agents and using patches to deliver pharmaceutical agents. Prereq. RGA 6202.

RGA 6206. Practical Aspects of Regulatory Compliance. 4 Hours.

Uses a series of practical exercises and discussions designed to offer students an opportunity to develop the ability to translate regulatory requirements for pharmaceutical, biologic, and medical device products into practical documents and broadly applicable research solutions. Topics include how to create practical documents based on regulations and guidelines; how to complete production batch records; how to conduct product testing and perform inspections; and, in general, how to effectively utilize Current Good X Practices (cGxP) requirements. Includes assignments that require students to research applicable regulatory and industry information as well as activities designed to aid in the comprehension of the regulations and in the review of real-life industry issues. Prereq. RGA 6200 and RGA 6203.

RGA 6210. Strategic Planning and Project Management for Regulatory Affairs. 4 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. The curriculum and assignments offer a chance to carefully study the function and format of presubmission meetings with U.S. and other global regulatory agencies, as well as understand their role in gaining regulatory approval for market sale. Prereq. RGA 6202, RGA 6220, or PJM 6000.

RGA 6211. Combination Products and Convergence. 4 Hours.

Examines the development of combination products, with an eye toward understanding FDA and international agency oversight, regulatory classifications, and interpretations of guidance documents. Medical products, no matter how well designed, can only do so much to address clinical problems today. In order to satisfy the therapeutic needs of the future, medical devices will be used in combination with drugs and biologics. This category of products covers everything from transdermal patches to drug-eluding stents. Tissue engineering, for example, employs cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices). Through a detailed study of real-world case studies, offers students an opportunity to weigh the larger economic, social, political, and clinical dimensions of combination products. Prereq. (a) RGA 6202 and (b) RGA 6200 or RGA 6205.

RGA 6212. Introduction to Safety Sciences. 4 Hours.

Introduces safety and surveillance regulations and principles for drugs, biologics, and medical devices. Offers students an opportunity to become familiar with the U.S. and global safety regulations, as well as related guidance from FDA, ICH, WHO, and CIOMS. Adopts a life-cycle perspective, beginning with use of preclinical data to anticipate human safety issues and continuing through clinical development and postmarketing. Examines combination products, safety information in regulatory documents (INDs, clinical study reports, NDA submissions), safety data analysis, quality management and CAPAs, and global safety initiatives (e.g., the WHO Uppsala Monitoring Centre). Prereq. RGA 6200 or RGA 6220.

RGA 6214. The Food and Drug Administration: Creation, Behavior, Regulatory Culture. 4 Hours.

Seeks to study the FDA on its own terms, from both inside and outside. Among many regulatory affairs specialists, the Food and Drug Administration represents an outside agent bent on slowing down the productive efforts to develop new drugs, medical devices, and biologics. In this view, the FDA is worthy of close examination only inasmuch as it impinges upon the development and marketing of particular products. Offers students an opportunity to understand the FDA as an organization beholden to its several stakeholder communities, including Congress, the executive branch, regulated industries, and patient advocacy groups. Appropriates theories and methods common to political science and sociology to explore the nature of regulatory cultures and limits of acceptable risks.

RGA 6215. Project Management in Early Drug Discovery and Development. 4 Hours.

Provides an overview of the processes common to researching and developing a new drug. 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-IND package. The lectures and reading materials focus on 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. Throughout the term, course material highlights the applicability and utility of project management tools. Prereq. BTC 6210, RGA 6100, and RGA 6201.

RGA 6216. The Medical, Social, and Financial Dimensions of Orphan Drugs. 4 Hours.

Examines the orphan drug development process, from discovery to FDA regulatory approval to postapproval marketing and distribution. Using selected case studies, offers students an opportunity to gain a strong understanding of how novel biomedical discoveries are translated into products used to treat relatively rare diseases. Topics include the role of patient advocacy groups in lobbying for research and development, the influence of gender and racial considerations on policy decisions, and the capacity of the federal government to support the research and commercialization of orphan drugs. The course situates its study of orphan drugs within the context of pharmaceutical firms’ reluctant shift away from big blockbuster drugs in favor of more personalized medicines. Prereq. RGA 6201.

RGA 6217. Biomedical Product Development: From Biotech to Boardroom to Market. 4 Hours.

Examines the evolution of the medical device and pharmaceutical landscape from a technological, regulatory, and financial perspective, as well as from a societal and cultural framework. Begins by recognizing that significant differences exist between small and mid-to-large medical device and pharmaceutical companies with regard to key variables in the current business environment. These differences extend to the opportunities available as well as the limitations and challenges faced by each. Discusses the symbiotic and potentially synergistic relationship that has developed between small, yet established, biotechnology companies and large medical device and pharmaceutical firms, as well as the impact of these relationships on the general economic environment. Prereq. RGA 6201 and RGA 6202. .

RGA 6218. Regulatory Affairs in an Entrepreneurial Environment. 4 Hours.

Covers the challenges shared by both the entrepreneur and the regulatory professional and how to successfully translate discoveries from the bench to the market. Since investors and prospective corporate partners view regulatory requirements a potential market barrier, it is crucial that the regulatory professional be able to demonstrate how the regulatory environment is conducive to a product’s development and commercial success. Using case studies and group projects, offers students an opportunity to develop regulatory strategies tailored to the characteristics of small and startup companies. Topics include developing a quality system from the ground up, assuring ongoing compliance with a minimum of resources, informing venture capital of regulatory hurdles, and employing regulatory considerations to create a sustainable competitive advantage. Prereq. BTC 6210, RGA 6201, and RGA 6202.

RGA 6219. The Advertising and Promotion of Drug and Medical Device Products. 4 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 FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), as well as professional guidelines of relevant organizations including Advamed, ACCME, ACP, PhRMA, and the AMA. Also 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 advertisements and case studies, including notable enforcement actions by the FDA and FTC, to illustrate and discuss subjects of interest. Prereq. BTC 6210, RGA 6201, and RGA 6202.

RGA 6220. Global Biotechnology Product Registration: E.U., U.S. Product Regulation. 5 Hours.

Provides a comprehensive and up-to-date analysis of the biotechnology product approval process within each of the world’s three most critical biopharmaceutical markets. From preclinical product development to postmarketing approval, explores aspects of biopharmaceutical regulatory analyses in the three regions of the world that together represent more than 75 percent of the global market for biopharmaceuticals.

RGA 6221. European Union Compliance Process and Regulatory Affairs. 4 Hours.

Provides a clear-cut picture of the European Union (EU) and how EU directives impact international business. By illustrating how companies need to approach compliance, offers students an opportunity to be guided through compliance issues and to gain an understanding of the relationship between compliance and CE marking. Discusses the risks and rewards of CE marking and an overview of liability laws in the EU. Prereq. (a) RGA 6201 and RGA 6202 or (b) RGA 6220.

RGA 6222. European Medical Device Regulations. 4 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, CE marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization. Prereq. RGA 6202, RGA 6205, or RGA 6220.

RGA 6223. Introduction to Canadian, Asian, and Latin American Regulatory Affairs. 4 Hours.

Covers the Common Technical Documents; General Guidance and GMPs; Global Harmonization Task Force documents; and regulatory affairs dealing with drugs, medical devices, biologics, and natural products. Examines multinational documents from Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), MERCOSUR, and Pan American and World Health Organizations. Discusses Latin American governmental regulations and guidance, as well as the guidance and regulations from FDA and General Agreement on Tariffs and Trade (GATT/WTO). Prereq. RGA 6200 or RGA 6220.

RGA 6224. Regulation of Biomedical Product Commercialization by Health Canada. 4 Hours.

Studies the regulatory requirements associated with all phases of biomedical product commercialization in the Canadian market by manufacturers. The Canadian market represents a significant opportunity for biomedical product manufacturers to export their goods into foreign geographies. Several factors have led patients in Canada to seek treatment modalities for their clinical symptoms and disease from both Canadian and non-Canadian sources. Reviews the Common Technical Document format for market approval applications, general Health Canada Guidances, good manufacturing practices (GMPs), and Global Harmonization Task Force documents. Examines multinational requirements and recommendations, including those issued by the North American Free Trade Agreement, the World Health Organization, and the U.S. Food and Drug Administration. Reviews the requirements of submissions to Health Canada by biomedical product manufacturers. Prereq. RGA 6200; regulatory affairs students only.

RGA 6225. Japanese Medical Device Regulations and Registration. 4 Hours.

Offers new and experienced regulatory professionals the opportunity to gain the knowledge and insight needed to successfully obtain Japanese medical device approvals. Japan is the second largest medical device market in the world, generating more than US$18 billion in device sales per year. As Japanese regulations and guidelines become more transparent, U.S. and EU manufacturers are flocking to this lucrative market. Prereq. RGA 6200 or RGA 6220.

RGA 6226. Canadian and Australian Medical Device Regulations. 4 Hours.

Explores the Common Technical Documents, General Guidance, GMPs, and Global Harmonization Task Force (GHTF) documents for medical device requirements in Canada and Australia. Offers students an opportunity to learn how to put together a medical device submission, identify two key submission pathways per product classification, and outline the postmarket requirements in both the Canadian and Australian markets. Prereq. RGA 6202 or RGA 6220.

RGA 6227. Emerging Medical Device Markets. 4 Hours.

Covers the Common Technical Documents, General Guidance, GMPs, and Global Harmonization Task Force (GHTF) documents for medical device requirements in emerging markets. The United States., European Union, Japan, Canada, and Australia comprise the five founding member countries of the GHTF. Yet, the most vibrant and challenging regulatory arenas of medical device development are those in emerging markets (e.g., the Pacific Rim, East Asia, the Middle East, and South America). Offers students an opportunity to practice putting together a medical device submission, identify two submission pathways per product classification, and outline the postmarket requirements. These practical lessons and regulatory skills are an asset to any regulatory professional in the global marketplace. Prereq. RGA 6202 or RGA 6220.

RGA 6228. Managing International Clinical Trials. 4 Hours.

Focuses on initiating, collecting, and managing data from multicountry clinical trials. The assigned material documents the growing internationalization of clinical research in biomedicine. For example, even trials carried out under the aegis of the U.S. FDA are likely to involve investigators in the European Union, China, India, Africa, or Latin America. The global nature of this research is due to the advantages that certain countries offer, including lower costs, flexible health infrastructures, and the presence of treatment-naïve populations. Multisource studies, however, present their own practical, legal, and ethical challenges. Offers students an opportunity to study the steps needed to conduct regulatory-compliant international trials. Through case studies and group projects, examines strategies to integrate clinical sites along common protocols and deadlines. Prereq. RGA 6220, BTC 6210, or RGA 6200.

RGA 6229. Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan. 4 Hours.

Studies basic requirements that medical device and other types of biomedical product manufacturing companies need to commercialize products in the Russian and Kazakhstan markets. Today Russia, together with other former Soviet countries such as Kazakhstan, remain some of the world’s fastest-growing export markets. In spite of recent economic difficulties, these geographic areas present many opportunities for biomedical product manufacturing companies that seek to expand into new markets. Offers students an opportunity to develop a practical understanding of the associated regulatory processes, through focus on real-world examples, the types of obstacles that companies may face, as well as how to overcome them. Prereq. (a) RGA 6200 and RGA 6202 or (b) RGA 6221 or (c) RGA 6222; regulatory affairs MS students only.

RGA 6230. Clinical Laboratory Management in Clinical Trials. 4 Hours.

Provides an overview of the management elements of the clinical laboratory aspect of clinical research. Offers students an opportunity to study the configuration of visits and identify the differences between safety-related testing, esoteric testing, and end-point testing. Identifies the challenges of qualifying a clinical laboratory and managing a clinical laboratory during the conduct of a clinical trial: protocol kits, logistics, local laboratory data, reference ranges, inspections, and regulatory requirements. Covers global aspects, such as data and method harmonization, blinding of data, transmission of data, and data amendments. Prereq. RGA 6201 and BTC 6210.

RGA 6233. Application of Quality System Regulation in Medical Device Design and Manufacturing. 4 Hours.

Introduces the Food and Drug Administration’s (FDA) Quality System Regulations (QSRs) and describes how these regulations can improve the safety and efficacy of medical device products. Discusses the legislative origins of QSRs, their historical evolution, as well as the details of how they are implemented. Examines case studies and empirical examples of QSRs that have been employed by individual medical device manufacturers during the product commercialization process. Offers students an opportunity to develop an understanding of FDA’s expectations for product design control; the structuring of quality system documentation; and principles of practical QSRs within the context of medical device manufacturing, packaging, and distribution. Encourages students to develop strategies for customizing QSRs to particular companies, device products, and manufacturing environments.

RGA 6234. Drug and Device Supplier Risk Management: Compliance and Processes. 4 Hours.

Seeks to provide a comprehensive overview of current supply chain risk-management practices and their impact on patient safety, product quality, and clinical effectiveness. Analyzes supplier oversight guidance documents, demonstrates how life-science companies strive to ensure compliance, and discusses the responsibilities of regulatory professionals in supply chain risk-management systems and regulatory issues stemming from poor supplier performance and management. Using case-based investigations and real-world examples, examines how to evaluate supply chain management systems as they relate to particular categories of biomedical products manufactured in specific contexts. Offers students an opportunity to obtain the skills and knowledge they need to customize effective supply chain risk-management methods within various global settings. Prereq. RGA 6100 and RGA 6202.

RGA 6235. Emerging Product Categories in the Regulation of Drugs and Biologics. 4 Hours.

Examines the development and commercialization pathways for several product categories, including new over-the-counter (OTC) products, neutraceuticals, nanotechnology products, and personalized medicine-based therapies. These emerging categories of drug and biologic products are not formally classified by FDA from a regulatory perspective. Evaluates the reasons why the 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.

RGA 6240. The Evolving Indian Regulatory Landscape. 4 Hours.

Offers students an opportunity to explore the Indian regulatory landscape and its relationship to the building of the Indian healthcare system, growing biomedical industries, and India’s expanding international trade. Compares the regulatory environments in the United States, European Union, and other emerging economies. Specific content includes discussions of the Central Drugs Standard Control Organization, the Drugs Controller General of India, the Drug and Cosmetics Acts, and the mechanisms for ensuring compliance with recognized good clinical practices. Also examines the manufacturing, sale, and international distribution of generic drugs. Prereq. RGA 6200.

RGA 6245. Regulation of Generic Pharmaceutical and Biosimilar Products. 4 Hours.

Describes the contrasting history and implementation of generic drug and biologic legislation in the U.S. market. Explores the specific technical differences between drug and biologic products and highlights areas where regulatory approval of generic products must differ between the two categories. Offers students an opportunity to better understand how the nonclinical and clinical development programs of generic drug and biologic products are constructed. Examines the relatively advanced state of the regulatory paradigm for biosimilars in the European Union. Prereq. RGA 6200.

RGA 6250. Financing and Reimbursement in Biomedical Product Development. 4 Hours.

Introduces the complex discipline of market access and pricing strategy for medical device, drug, and biologic products. As cost and relative efficacy drivers become increasingly important to market biomedical products successfully, life-sciences regulatory professionals must evaluate regulatory compliance criteria in relation to reimbursement and product pricing concerns. Regulatory professionals must also be involved in demonstrating 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, as well as their resulting implications for biomedical product development, manufacturing, and commercialization, with an overall objective to develop comparatively and financially informed regulatory systems. Prereq. RGA 6200.

RGA 6280. Advanced Writing on International Biomedical Topics. 4 Hours.

Seeks to hone the research and composition skills of regulatory affairs professionals. Offers students an opportunity to develop a highly efficient ability to craft accurate and detailed summaries, analytic essays, and research papers. Each term the course focuses on a particular country or region of the world. Specific topics include healthcare epidemiology; healthcare delivery and financial systems; progress in biomedical research; government involvement in the healthcare industry; regulatory systems governing drugs, biologics, and medical devices; and the conduct of clinical trials. Concludes by asking students to provide recommendations on how to improve biomedical research and markets in the focused country or regions.

RGA 6300. Practical Applications in Biomedical Product Global Regulatory Affairs. 4 Hours.

Uses a series of practical exercises and discussions designed to offer students an opportunity to exercise their ability to translate global regulatory requirements for pharmaceutical, biologic, and medical device product commercialization into submission-ready documents and broadly applicable regulatory science solutions. Topics include creating practical documents based on regulations and guidelines, completing production batch records, conducting product testing, performing inspections, and effective utilization of GxP requirements. Incorporates both group and/or individual assignments that require students to research applicable regulatory and industry information, as well as activities designed to aid in the comprehension of global regulatory issues. Uses case-based methodologies to enable real-world application of topics and regulatory issues discussed during the course. Prereq. RGA 6200 and RGA 6203; regulatory affairs MS students only.

RGA 6310. Regulatory Documentation Processes. 4 Hours.

Examines the nexus of professions, practices, and institutions that constitute the field of biomedicine. Explores the historical roots and cultural foundations of biomedicine. Maps the industrial terrain and identifies opportunities and issues for professional communicators. Students research and report on current changes in the biomedical industry, focusing on identifying new opportunities for writers in biomedicine. Offers students an opportunity to acquire research and writing skills and to develop the ability to think in terms of complex institutions so as to locate and articulate opportunities for professional communication.

RGA 6370. Regulatory Writing: Medical Device Submissions. 4 Hours.

Examines the process of writing medical device submissions for regulatory agencies both nationally and internationally. Topics include device regulations, the device development process, and clinical study documents. Offers students an opportunity to practice communicating complex scientific information in various documents, including investigators’ brochures, clinical trial reports, and IDE/510k submission components.

RGA 6380. Regulatory Writing: New Drug Applications. 4 Hours.

Examines the process of writing drug submissions for regulatory agencies both nationally and internationally. Topics include drug regulations, the drug development process, and clinical study documents. Offers students an opportunity to practice communicating complex scientific information in various documents, including investigators’ brochures, clinical trial reports, and IND/NDA submission components.

RGA 6920. Internship Reflection. 1 Hour.

Offers an independent study designed to allow students to reflect on both the theoretical knowledge that they have learned while pursuing their degree at Northeastern University and the practical experience that they have gained in an internship. Students should aim to create a unique, original, and ultimately applicable project that demonstrates an in-depth understanding of current markets, future trends, and global shifts in regulatory affairs. Prereq. COP 6940.

RGA 6961. Internship. 1-4 Hours.

Matches the student with a company or public-sector agency engaged in pharmaceutical, medical device, and biotechnology regulatory affairs. The internship provides the student with the opportunity to apply his or her knowledge in the subject area to practical problems. Prereq. RGA 6100 and RGA 6200 and RGA 6201 and RGA 6202.

RGA 6962. Elective. 1-4 Hours.

Offers elective credit for courses taken at other academic institutions.

RGA 6964. Co-op. 0 Hours.

Provides eligible students with an opportunity for work experience.

RGA 6966. Practicum. 1-4 Hours.

Provides eligible students with an opportunity for practical experience.

RGA 6970. Seminar. 1-4 Hours.

Offers an in-depth study of selected topics.

RGA 6980. Capstone. 1-4 Hours.

Offers students an opportunity to integrate their course work, knowledge, and experiences into a capstone project.

RGA 6983. Topics. 1-4 Hours.

Covers special topics in regulatory affairs.

RGA 6995. Project. 1-4 Hours.

Focuses on in-depth project in which a student conducts research or produces a product related to the student’s major field.

RGA 7961. Internship. 1-4 Hours.

Provides students with an opportunity for internship work.

RGA 7962. Elective. 1-4 Hours.

Offers elective credit for courses taken at other academic institutions.

RGA 7976. Directed Study. 1-4 Hours.

Offers students an opportunity to carry out an individual reading and research project under the supervision of a faculty member. The directed study format allows for the thorough study of a particular topic not covered in-depth or the study of a subject not typically covered in the curriculum. A directed study proposal must be approved by the faculty sponsor, division head, and dean of academic affairs.

RGA 7978. Independent Study. 1-4 Hours.

Offers independent work under the direction of members of the department on a chosen topic.

RGA 7980. Capstone. 1-4 Hours.

Offers students an opportunity to integrate their course work, knowledge, and experiences into a capstone project.

RGA 7983. Topics. 1-4 Hours.

Covers special topics in regulatory affairs.

RGA 7990. Thesis. 1-4 Hours.

Offers thesis supervision by members of the department.

RGA 7994. Thesis Continuation—PT. 0 Hours.

Offers continuing thesis supervision by members of the department.

RGA 7995. Project. 1-4 Hours.

Focuses on in-depth project in which a student conducts research or produces a product related to the student’s major field.

RGA 7996. Thesis Continuation. 0 Hours.

Offers continuing thesis supervision by members of the department.