Research Forums: Drugs and Devices in Research: An Introduction to Navigating FDA Oversight Requirements

Drugs and Devices in Research: An Introduction to Navigating FDA Oversight Requirements

Presenter: Jacob Rome, Administrative Director, UW FDA Regulated Research Oversight Program

The virtual Research Forums series is open to UW–Madison faculty, staff, and students and UW Health employees.

The FDA is responsible for overseeing the use of drugs and devices in clinical investigations, but what does that actually mean? Does it matter that you are not evaluating the safety or effectiveness of the drug or device used in a research study? How does the use of an approved drug or device differ from the use of an investigational product?

Register today to learn the answers to these questions and gain an understanding of how FDA drug and device requirements apply to research activities including:

• An overview of the FDA’s drug and device regulations;
• Guidance on identifying what regulations apply to your research activities;
• Information on the practical effects of conducting “FDA Regulated” research;
• Tips to  ensure compliance in all FDA Regulated research.

Please note that this session will be recorded.

CLICK HERE to register …