Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices

If you’re designing a study with a drug or device (e.g., lab test, software application, or other device product) – do you know if you need an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) Application? Can your study be exempt from the IND or IDE regulations? Attend our Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices training! This session is a collaboration with Penn Medicine’s Office of Clinical Research and will explain what IND and IDE exemptions are, criteria that must be met, and the review process at Penn. This session may be of interest to those in Penn Medicine, Penn Dental, and Penn Engineering.

All sessions will last 60-90 minutes to allow time for Q&A. Sessions will be held via Zoom. Zoom links will be distributed to attendees via email about 24 hours before each session begins.

Any questions can be directed to Diana Floegel, Senior Regulatory Analyst and IRB 8 Chair, at floegeld@upenn.edu.

Sign up for the sessions HERE.