SEPI: IND Submissions 101

Dec 05, 2013 (Thu) | 8:30 AM -9:45 AM
LI Ka Shing Center, LK101 : Stanford, CA

An Investigational New Drug Application (IND) is a request for authorization from the FDA to administer an investigational drug or biological product to humans, exempting the drug/biologic from premarketing approval requirements so that experimental clinical trials may be conducted. In this workshop, a panel will provide the basics of IND submissions and lead a discussion following the presentation. Speakers will cover Stanford resources for IND submissions including SPARK, CCTO, and Spectrum and share lessons learned from investigator-initiated IND studies.

Department:  Spectrum: Center for Translational and Clinical Research and Education

Contact: Jessica P. Meyer | 650-498-6140 | jpmeyer@stanford.edu

Presenter(s):

  • Lee Doherty, EdM Regulatory Manager, Stanford Cancer Clinical Trials Office
  • Kevin Grimes, MD Co-Director, Spark
  • Alfred Lane, MD Professor, Dermatology
  • Wendye Robbins, MD Clinical Associate Professor, Anesthesia
  • Jennifer Brown, RN Manager of Regulatory Services and Education, Spectrum

        Course Website