These goods and services are a large and growing part of the U.S. and world economy, with some estimates being that more than one-quarter of U.S. food and medical products are regulated by the FDA alone. Students may concurrently enroll in this practicum course and an externship. Prerequisite: J.D. Founded in 1919, the School of Foreign Service the oldest school of international affairs in the U.S.  offers undergraduate and graduate programs in international affairs, regional and comparative studies and security studies. This is either a four or a five credit course, depending on the number of fieldwork hours/week. Contact Us maincampuseval@georgetown.edu Interested LL.M. Does a regulatory approach to the prevention of NCDs imply coercion? Note: This is a required course for the Food and Drug Law Certificate. Evaluations for Fall 2020 For the Fall 2020 semester, an evaluation report will be […] Beyond health insurance and the delivery of health care, goods and services related to individual and public health are highly regulated in the United States, and often serve as a basis for international regulations. LAW 1209 v02 O’Neill Institute Practicum: Regulating Alcohol, Tobacco & Food in International and Comparative Law A background in biologics or pharmaceuticals is not required, although completion of a basic patent law or a food and drug law course is recommended. The Registrar’s Office administers online course evaluations only, paper evaluations are no longer offered. From a high-level, this includes the regulation of health professionals, health systems, and medical or food products impacting human health. In addition to the final paper, students will be graded on class participation, individual presentations and group exercises, an example of the last being a hypothetical case study of exports, with students taking up the role of legal advisors based in either the importing country or the exporting country. During the course, we will confront some important over-arching questions. This course examines the special legal and policy issues arising from the use of intellectual property rights in the pharmaceutical and biotechnology fields. Currently, there is no text or case book on this subject. program or on a standalone basis. Do you require a dean's certification from my home law school? Continue Reading. These rules are increasingly being used by foreign investors, including trans-national corporations, to challenge domestic regulations such as public health measures. Degree John J. DeGioia (C’79, G’95) Washington, DC President, Georgetown University. Phone: (202) 661-6664 Students will be equipped with an understanding of specific issues, such as the role of law compared with policy, the strengths and weaknesses of different regulatory strategies and the role and responsibilities of the relevant industries in promoting the right to health. This course explores the legal, regulatory and policy issues that shape the research, development, and commercialization of drugs and biologics in the United States and Europe, with a particular emphasis on public policy issues. Students pursuing the Certificate as part of an LL.M. A biotechnology background is not necessary. This course will introduce students to the foundational laws and policies governing the production and distribution of foods, drugs and medical devices in the United States, focusing on the Federal Food, Drug, and Cosmetic Act (the "Act") and the role of the Food and Drug Administration in enforcing the Act. J.D. Legal work in California is driven by the tech companies, real estate and entertainment industries, but corporate work thrives there as well (especially in Southern California). At Georgetown Law, students learn the law in the place where laws are made. students must complete the required first-year program prior to enrolling in this course (part-time and interdivisional transfer students may enroll prior to completing Criminal Justice, Property, or their first-year elective). The course will then conclude with an examination of several contemporary problems, such as the safe and effective use of human drug products, infectious-disease prevention and control, ethical research practices, and rationing and allocation of limited resources. Larry Cunningham, a Georgetown Law graduate with over a decade in higher education, took over the helm at the Charleston School of Law in June. Requesting a Letter of Certification Eligiblity for Certification The Office of the University Registrar can … Proper nutrition is one of the many contributor’s to overall health and could be one of the most cost-effective approaches to address many of societal, environmental and economic challenges facing the world today. Students will also learn how to use epidemiological data to craft compelling arguments in support of adoption of NCD-related laws and policies and to defend these laws when challenged by industry. Students will participate in a two-hour/week seminar and carry out 10 hours/week of project work under the direction of the course professors. This course will also identify the major international non-governmental stakeholders, and the multi-lateral schemes and treatises in which they operate that are intended to assist in the convergence of pharmaceutical laws and regulations. A take home exam is required for the two-credit section. SEMINAR: In the two-credit, graded, seminar portion of the practicum, students will utilize legislative and administrative materials as well as case law to become familiar with the processes by which the federal government regulates tobacco and personal-care products, and to critique both the statutory framework and FDA’s performance in protecting consumers. Course evaluations are conducted using the CoursEval system. Beyond the law itself, we will consider the scientific, economic, and ethical principles implicated by legal decisions concerning food. Part IV of the course will explore the legal, regulatory and policy issues that arise in the delivery and use of global health technologies, particularly supply chain contracting, drug resistance, and post-market surveillance in low- and middle-income countries. Please use this Certificate of Enrollment Request Form to request certification of enrollment or graduation. 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