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