Speaker:
Jeremy D. Ollerenshaw, PhD

When: 5:00 PM, November 10, 2022

Abstract:

This talk will focus on the requirements of the FDA for simple and complex biomedical products that may include bench, preclinical and clinical studies, validation and verification studies, product stability and biocompatibility. Other requirements will also be discussed such as product packaging and labeling. These are all aspects that are addressed in FDA submissions and are usually handled by a broad team. We will discuss how these all fit together. Additionally, the strategy of making applications to FDA for review and approval of biomedical products will be covered. This will be an interactive discussion, with plenty of time for Q&A, of regulatory considerations in developing medical devices and biotechnologies for clinical use, and for their approval by the US FDA.

Zoom Meeting: https://fiu.zoom.us/j/98265123186

Meeting ID: 982 6512 3186 Passcode: 259WgL

Flyer for Event: Link