This course will offer best practices when conducting clinical trials using FDA approved and
non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA. This workshop will address the following information:

• Do I even need an IND for my investigation?
• What are some examples of trials requiring an IND and examples of studies that are IND exempt?
• What should I include in my IND submission to the FDA?
• What happens after I submit my IND application to the FDA?
• How and when should I report Serious Adverse Events (SAEs) once I have an IND?
• Is my trial required to be registered on Clinicaltrials.gov?
• Roundtable discussion about the IND process and general questions from participants

Link to register: https://cfx.research.unc.edu/res_classreg/browse_single.cfm?New=1&event=DF835EF8715076EFE82913686BA633C256FA4FBB