2013 IND/IDE Workshop: FDA Drug and Device Application Workshop
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.
The target audience encompassed clinical investigators and others on the study team responsible for submitting and maintaining FDA IND and/or IDE applications.
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.
Colloquium Room, Room 906
Boston University Photonics Center
8 St Mary’s Street, Boston, MA
Take the B line (Boston College) and get off at Boston University Central Station
57 Bus, T Stop St. Mary’s Street
St Mary’s Street (Inbound) or Marsh Plaza (Outbound)