IRB 101: Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices

If you’re designing a study with a drug or a device – 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 will explain what IND and IDE exemptions are, criteria that must be met, and the review process at Penn.

Target Audience: Penn Medicine and Penn Dental faculty, research staff, post docs, and students.

Sign up for the sessions here.

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