Academic Courses in Research

Clinical & Translational Research Training 

In particular, the following courses may be of interest to staff conducting human subjects research:

MTR 510 – Introduction to Clinical and Translational Research – This course provides an introduction to biostatistics, trial design, regulatory affairs and the mechanics underlying the drug approval process.

REG 611 – Clinical Study Management – This course focuses on the practical aspects of executing clinical trials in an academic environment in a GCP compliant fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies.

REG 610 – Fundamentals of FDA Regulation - This introductory course provides an overview of Regulatory Affairs in relation to three key areas of development: Drugs, Biologics, and Medical Devices. Throughout the course, practical issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed.

Contact them for more information or to register:

Non-Degree Clinical Research Training Program Course Offerings

The Center for Clinical Epidemiology and Biostatistics (CCEB), the Department of Biostatistics and Epidemiology (DBE), and the Graduate Group in Epidemiology and Biostatistics (Graduate Group) offer a series of clinical research methods courses designed primarily for residents, fellows, and faculty interested in careers as clinical research collaborators.

Master of Bioethics

The Penn Master of Bioethics program is one of the nation's premier programs for bioethics education, attracting exceptional students from both the US and abroad. The program admits highly accomplished professionals who work in the bioethics-related fields of medicine, nursing, law, dentistry, social work, genetic counseling, regulatory affairs, public policy, veterinary medicine, and industry, as well as outstanding students in other professional degree programs at the University of Pennsylvania

Clinical Research and Public Health Training Options

This newly developed site is designed to assist clinicians and basic scientists within the University of Pennsylvania School of Medicine who seek training or additional, supplemental training in clinical research, bioethics, and/or public health. It includes brief overview training options to Master's and PhD Degree programs in clinical research.

 Master of Regulatory Affairs (MRA) Program

The MRA program is designed to prepare professionals to play key roles in bringing innovative products to market while also ensuring that products are safe and effective. Graduates will be trained in the skills necessary to maximize compliance and minimize risk in the development of FDA-regulated products and will learn both the foundation and application of science-based clinical investigation and corresponding regulations. This is accomplished through a 10-credit unit curriculum consisting of coursework and an experiential capstone project.

Take a course with us! Review the REG courses then scroll down to the bottom of the page to complete the course request form.