FDA Conference: IND/IDE Overview and Audit Preparedness

The Center for Clinical and Translational Science in collaboration with The Ohio State University Office of Responsible Research Practices and Nationwide Children’s Hospital will host an FDA-focused conference entitled “FDA Regulated Research: IND/IDE Overview and Audit Preparedness.” The conference will include a number of speakers from academic institutions, regulatory experts, The Ohio State University, Wexner Medical Center, OSU College of Veterinary Medicine, and Nationwide Children’s Hospital and will focus on the following key topics:

• The pre-human IND/IDE process
• IND/IDE process for human studies
• Quality Management Plans
• Risk-based Monitoring