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There is now a CONTENT FREEZE for Mercury while we switch to a new platform. It began on Friday, March 10 at 6pm and will end on Wednesday, March 15 at noon. No new content can be created during this time, but all material in the system as of the beginning of the freeze will be migrated to the new platform, including users and groups. Functionally the new site is identical to the old one. webteam@gatech.edu
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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):
This course is designed for anyone directly involved in conducting investigator-initiated trials:
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.