The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IDE Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).
This workshop will:
Presenters
Alysa Vereen, PharmD, Regulatory Affairs Scientist, Duke University School of Medicine
David Jensen, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine
NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.
See also: IND workshop Mar 5