Term or Semester:
Day and Time:
Wednesdays, 2:00pm - 5:00pm
Quarter Dates:
January 8 - March 12, 2025
Semester Dates:
January 8 - April 16, 2025
Campus:
UCDC
Description:
This course provides a comprehensive exploration of the U.S. regulatory system for drugs and medical devices, covering FDA approval pathways, post-market surveillance, and opportunities for policy improvement. Designed for students interested in healthcare, policy, or nonprofit leadership, the course examines accelerated approvals, breakthrough designations, Medicare coverage, and adverse event reporting. Students will also explore how marketing strategies, conflicts of interest, and evolving regulatory practices impact clinical practice and patient safety. This course equips students with the knowledge needed to engage with the complexities of regulatory science and therapeutics in various healthcare and policy settings.
About the Instructor:
Dr. Rita F. Redberg is a cardiologist who practices general and preventive cardiology. She is passionate about helping her patients adopt healthful lifestyle behaviors to reduce their heart disease risk and stay healthy. She also has an interest in promoting high-value health care, an approach that emphasizes delivering appropriate treatments while avoiding tests or therapies with no known benefits.
In her research, Redberg looks at how the assessment of medical technology's safety and effectiveness influences – and is influenced by – public health policy. In particular, she studies high-risk medical devices and women's inclusion in clinical trials for such devices.
As editor of JAMA Internal Medicine, a journal of the American Medical Association, from 2009 to 2023, she spearheaded the publication's new focus on health care reform and less-is-more medicine, a movement to reduce unnecessary interventions.
Redberg earned her medical degree from the Perelman School of Medicine at the University of Pennsylvania. She completed a residency in internal medicine and a fellowship in cardiology at Columbia University Medical Center. She completed a fellowship in noninvasive cardiology at the Mount Sinai Health System. She also has a master's degree in health policy and administration from the London School of Economics and Political Science.
Requirement for ALL semester students:
The four weeks from March 24 to April 18 will be spent in a special topics module taught by Dr. Jimmy Ellis (or designated instructor) on Wednesdays from 6:30 to 9:30p.m. This module will account for 15% of the seminar final course grade.
Your selected seminar will begin the week of January 6 and your seminar instructor will officially be your instructor of record for the term, responsible for computing and submitting final course grades at the end of the term.
**NO additional registration required.
Course ID:
UCDC191H01W25