The development of a new drug is a complex, lengthy, and expensive process. Since regulatory approval is required before a company can bring a drug to market and generate revenue, it remains one of the riskiest endeavors in the biopharmaceutical industry
In this course, you will explore the drug development process—from preclinical efforts to evaluate a drug's pharmacologic properties for safety and efficacy to the clinical trials required for regulatory approval. You will examine the objectives, mechanics, and ethical considerations of testing investigational drugs in human clinical studies. The course also covers how the U.S. Food and Drug Administration (FDA) reviews new drug applications and the post-approval requirements imposed on biopharmaceutical sponsors.
Through real-world case studies, you’ll gain insight into the science and regulatory frameworks guiding drug development, as well as the challenges biopharmaceutical professionals face in bringing a new drug to market. These case studies illustrate the complexities of the process, providing a practical perspective on the regulatory and business considerations influencing the industry.
Designed for professionals across disciplines who are currently working in—or considering a move to—the biopharmaceutical industry, this course offers a foundational understanding of drug development and equips students with the knowledge needed to navigate the biopharmaceutical landscape.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114, 30.0 hours.
This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
