GCP: The IND, How to Gain Approval for Clinical Trials in the USA 2016

Topics

• 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

Who should Attend

• 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