Best Practices for Preparation and Maintenance of Sponsor-Investigator INDs and IDEs

Summary

This was a full day, 2-part workshop on the FDA Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE). Held on Friday October 11, 2013, this workshop was open to clinical researchers at Boston University/Boston Medical Center, and the New England Clinical and Translational Science Institutes (CTSIs). The speaker was Bruce K. Burnett, PhD, RAC (US, EU), Assistant Professor of Medicine in Clinical Pharmacology and Director of Regulatory Affairs at Duke Translational Medicine Institute.

Dr. Burnett has over 25 years of pharmaceutical experience involving drug development, quality control/assurance and regulatory affairs. He is responsible for creating and leading the Regulatory Affairs group at Duke that provides all aspects of regulatory assistance to investigators performing clinical research, as well as providing GLP, GMP and GCP guidance.  The RA group assists investigators holding over 100 INDs in multiple therapeutic areas involving biologics, drugs, cell therapy, and gene therapy.

The target audience encompassed clinical investigators and others on the study team responsible for submitting and maintaining FDA IND and/or IDE applications.

Location

  • Boston University Photonics Colloquium Room
  • 9th Floor, Room 906, 8 St. Mary’s Street, Boston MA, 02215

Slides

Video Link

Bruce K. Burnett_BU Workshop on FDA Applications
Click here to see the video.

This event was supported by the BU Center for Future Technologies in Cancer Care, the BU Clinical Translational Science Institute (CTSI), and BUMC Office of Clinical Research, and the BU Department of Medicine, in collaboration with the Regulatory Affairs Office of the Duke Translational Medicine Institute.