Investigational New Drug Applicaton (IND) Forms: Updates and Best Practices
Sponsor(s): Office of Regulatory Affairs and Quality (SOM), Biomedical Engineering (BME), Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
The Duke Office of Regulatory Affairs and Quality (ORAQ) is hosting a one-hour workshop on IND forms. Forms FDA 1571, 1572 and 3674 will be reviewed, all of which are required for initial IND submissions for investigational drug studies. We will focus on recent changes and best practices, and discussion will be encouraged!
This workshop is recommended for regulatory coordinators, study coordinators, and anyone else who may be involved in the preparation of forms for IND submissions to the FDA.
For more information and to register, visit the ORAQ website: http://bit.ly/2SgpTQ7
Contact: Susan Nagorski