General Academic Information
• Your class schedule for the quarter you are studying at the University of Chicago will be made available to you when you arrive.
• Most course materials are available on the online platform Canvas.
• Any additional course books or materials will be purchased for you.
Choosing Your Elective Course
• Students rank order their course preferences from a pre-approved list, but are not guaranteed placement in their electives of choice.
• Students are graded on an A through F scale; these grades carry a specific weight in calculating official grade point average (GPA).
• By the end of the quarter, students must complete 300 units of course credit with passing grades and with a minimum GPA of 2.0.
• For every hour of class it is expected that you will have three to six hours per day of homework outside of class.
• For time management strategies and study skills, check here.
• Academic integrity is of paramount importance to us at the University of Chicago and we want you to be well informed of acceptable practices and procedures that you must follow as a student. Please review the following links to the Student Manuals for the Graham School and University.
University of Chicago - CEU Curricula
- Clinical Trials Management
Course Modules in Spain – July 2017
· The Drug Development Process
o This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost/benefit analyses in clinical development, Phase I-IV clinical trials, and an introduction to the special problems of each phase.
· Good Clinical Practices
o This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.
Course Modules in Chicago - Autumn Quarter 2017
· Fundamentals of Site Management
o This course covers the process of coordinating and managing a clinical study from the perspective of the study site. Students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study initiation visit to closing out a study. The course will focus on the operational, interpersonal, and data-management aspects of the process.
· Fundamentals of Clinical Monitoring
o This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.
· Statistical Concepts for Clinical Research
o This course introduces basic statistical concepts, such as hypothesis testing, the meaning of P value, and power determination. Other concepts with particular relevance to clinical research design and monitoring-such as the importance of randomization and randomization procedures, stratification, crossover designs, nonrandomized concurrent control studies, and the use of historical controls-will also be introduced
· Project Management and Leadership in Clinical Trials
o This course will examine the role of stakeholders and their role in adding value to the organization. Given the complexity and dynamism of health care organizations, it is necessary to understand how different forms of leadership influence and determine the course of development and growth.
- International Political Economy
Course Modules in Spain – June 2017
· Political Risk Analysis
o Provides a review of the tools and assumptions employed in analyzing political risk for international business. The term political risk refers to the possibility that investors or corporations operating in foreign nations will lose money or make less money than expected due to political decisions, conditions, or events occurring in the country or within the global marketplace.
· International Organizations
o Foundations of international organizations and their effects on world politics will be examined, spanning from the assumptions of neo-realist perspectives to more broad views to include the UN and global-spanning NGOs and how these different ways of thinking effect international organizations.
o This introduction to international macroeconomics and current international financial issues will focus on the interplay of policies and events, trade deficits, emerging market economies, fiscal policies, international financial architecture, globalization of financial markets, and more.
Course Modules in Chicago – Autumn Quarter 2017
· Money and Banking
o Traditional topics such as quantity theory, Phillips curve, and the money creation process, as well as models of financial crises, New Keynesian approaches to modelling money, monetary policy, and institutional issues in European and U.S. monetary policy, and the 2008 financial crisis will be examined.
· Politics of Globalization
o The causes and impact of globalization and its driving forces of economics and technology will be studied across topics such as, the Internet, Wall Street, climate change, propagation of ideas, energy dependence, terror and criminal networks, NGOs, and culture.
· International Trade and Finance
o Participants will be introduced to the concept of international trade and the institutional and policy contexts in which trade is transacted, to include services across international boundaries, trade and supply chain management, and the financial markets that facilitate (or impede) trade.
· International Law
o An introduction to international law to include sources, institutions, adjudication, and finance. We will consider how formal and informal legal conventions shape how states and actors participate in a range of activities such as shipping, immigration, and protecting biodiversity.
- Business of Biotechnology
Course Modules in Spain – July 2017
· Regulation of Biotech Products in Global Pharma Market
o This course provides an overview of the global pharmaceutical industry and insight into the regulatory process, from drug discovery to the approval of new pharmaceutical products or medical devices. Topics include research and development, pre-clinical and clinical trials, manufacturing, marketing approval, product launch and the post-marketing phase. Students will become familiar with related terminology and timelines.
· Intellectual Property and Patent Law in Biotechnology
o This course provides an overview of legal issues affecting the biotechnology and pharmaceutical industry, with a special focus on intellectual property rights and patent law. Topics will include basic and practical aspects of intellectual property, the uses of biotechnology patents, the patent-granting system in the US, and patent enforcement.
Course Modules in Chicago – Spring Quarter 2018 (course descriptions will become available January 2018)
· Building the Business Plan
· Capital Markets and Biotechnology
· Managing Operation and Board Relations
· Licensing and Collaboration Agreements