Curriculum

CRS 601 - Regulation of Pharmaceuticals, Biologics, and Medical Devices
As communities face new challenges and threats of disease, science continues to evolve and present solutions to many of humanity’s problems. While these advancements may mean new solutions are available, the cost and consequences of these “solutions” and new technologies are not always readily apparent. To ensure the safety of the American public and populations all over the world, organizations like the U.S. Food and Drug Administration (FDA) have been developed to tackle important questions of regulation of food, drugs, medical devices, and even things like AI or biologics. As a result, dealing with the regulatory requirements for pharmaceuticals, medical devices, and biologics has become increasingly complex in recent years thanks to a myriad of forces transforming science, the medical industry, and everyday life. To better understand this complex regulatory environment and its importance in maintaining transparent safety and efficacy of these products, Regulation of Pharmaceutics, Biologics, and Medical Devices will provide students with a foundation in regulatory sciences essential for taking a product from concept all the way to market.

CRS 602 - Foundations of Clinical Trials

Foundations of Clinical Trials is intended to teach students the basic principles of developing, executing, and managing clinical trials by focusing on developing a strong foundation for understanding the complex processes of clinical trials. Students will learn about the methods needed to conduct clinical trials, the policies and agencies that guide them, as well as the importance clinical trials have for the advancement and translation of scientific discoveries. Industry and legal experts along with Cedars-Sinai faculty and staff, will teach the theoretical foundations of clinical trials and their practical application in real-world settings. Further, this course will look at bioethical and practical issues, and examine how clinical trials are conducted, documented and managed.

CRS 603 - Next Generation Regulatory Topics

Next Generation Regulatory Topics examines how rapidly evolving innovations are transforming the regulatory landscape across the pharmaceutical, biotechnology, and healthcare sectors. Students will engage with topics such as digital therapeutics, AI in precision medicine, gene and cell therapies, cannabis and cosmetics regulation, and broader trends in emerging technologies. Through expert-led modules and real-world case examples, students will analyze how these innovations challenge traditional frameworks, raise new ethical and policy questions, and influence clinical development timelines, market strategies, and compliance requirements. Emphasis is placed on developing practical insight and critical thinking skills aligned with professional competencies in regulatory science, compliance, risk management, and innovation strategy.