Kristen Foss, Ph.D., R.A.C.
Regulatory Affairs Scientist
Duke University School of Medicine

This workshop will offer best practices when conducting trials using FDA approved and unapproved drugs or substances (including biologics). It will give an overview of the IND application process and the regulatory obligations of the sponsor-investigator once an IND is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation.

This workshop will address the following questions (and more):

• What is an investigational drug?
• Do I need an IND for my investigation? What are some examples of trials requiring an IND and examples of studies that are IND exempt?
• When do I need an IND for an investigation using dietary supplements?
• When should I consider having a Pre-IND meeting with the FDA?
• What information needs to be included in my IND application?
• What happens after I submit my IND application to the FDA?
• What are the reporting requirements once my IND is effective?
• How and when should I report serious adverse events (SAEs) once I have an IND?

This course is designed for anyone directly involved in conducting investigator-initiated trials:

• Investigators
• Regulatory Personnel
• Clinical Research Nurses
• Clinical Research Associates

Kristen Foss, Ph.D., received her undergraduate degree in biology from South Dakota State University and then worked as a research associate at the Translational Genomics Research Institute in Phoenix, Arizona. Foss conducted her graduate research at Duke University, where she earned her Ph.D. in Pharmacology with a certificate in Cell and Molecular Biology. During her graduate training, Foss was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. She was also selected to participate in the Duke Scholars in Molecular Medicine Program in Oncology and Regenerative Medicine. Foss holds the US Regulatory Affairs Certification (R.A.C.) from the Regulatory Affairs Professional Society.