GCP: The IND, How to Gain Approval for Clinical Trials in the USA 2016 is a webinar that covers topics such as:
- 21 CFR 312
- FDA regulatory overview
- Good Clinical Practice guideline requirements study conduct
- 21 CFR 812
- IND application and its components
- What is the IND and when it is needed
- Circumstances requiring an IND amendment
- Requirements under an Investigational New Drug Number
- Briefly discuss the review the approval process for the IND
- Reporting requirements under an IND
GCP: The IND, How to Gain Approval for Clinical Trials in the USA 2016 is intended for:
- Healthcare interested in exploring the field of Clinical Research
- Human Subjects Research
- Administration in charge of Clinical Research, Clinical Research Sites
- Clinical Research Coordinator positions
- Principal Investigator positions, Sub-Investigators
- Contract Research Organizations , Clinical Research Associates, Regulatory Coordinators
