Introduction to Medical Product Development (ANTH 627/427)
University of Maryland, College Park
Department of Anthropology
Faculty: Dr. Rob Bienvenu, Ph.D., RAC, CIP
Tuesday, 28 May to Friday, 5 July 2019
Brief Course Description:
How are healthcare products developed today, and what is the role of the social and behavioral sciences in this process? This course provides an introduction to clinical research and the pathways through which medical products are approved by agencies such as the U.S. Food and Drug Administration (FDA). We examine the historical development of modern clinical research, regulatory requirements for approval of drugs, biologics, and medical devices, and current regulatory science issues that may be informed by the social and behavioral sciences (SBS). Students learn how theoretical frameworks and methodological tools from the SBS are applied in clinical research, with focus on topics such as real world evidence (as framed by the FDA) and digital health technologies.
The course requirements include a "real-world" project: working in teams, students will develop a deliverable suitable for a NGO, industry, or regulatory agency setting.
In addition to the social and behavioral sciences, students from diverse disciplinary backgrounds interested in modern medical product development will find the course to be a relevant introduction to the field.
The course is taught in a blended format, with class meetings in-person every Tuesday evening from 6:00 - 9:30 pm, and "on-line" most Thursdays, with activities conducted asynchronously on Canvas.
Undergraduate - ANTH 427 https://ter.ps/iw4
Graduate - ANTH 627 https://ter.ps/iw5
Please contact Dr. Rob Bienvenu if you have any questions.
Adamo, Joan E., Robert V. Bienvenu II, F. Owen Fields, Soma Gosh, Christina M. Jones, Michael Liebman, Mark S. Lowenthal, Scott J. Steele. 2018. “The Integration of Emerging Omics Approaches to Advance Precision Medicine: How Can Regulatory Science Help?” Journal of Clinical and Translational Science. 2(5): 295-300. https://doi.org/10.1017/cts.2018.330