The NINDS Topics in Clinical Research Seminar Series Presents, The Nuts and Bolts of IND Submission and Maintenance
Please log on for the next Topics in Clinical Research where we welcome Heather Fitter, MD, Clinical Team Leader Division of Neurology 2, Office of Neuroscience, Center for Drug Evaluation and Research, FDA as she talks about The Nuts and Bolts of IND Submission and Maintenance.
Topics covered include:
- Offering guidance on assembling an IND submission to ensure you receive a "may proceed" letter instead of a "complete response" letter
- Detailing the internal process of IND review at the division level
- Explaining how to determine if a study is exempt from needing an IND
- Outlining sponsor responsibilities if a protocol is approved to proceed
- Q&A to follow!
Dr. Heather Fitter is a clinical team leader in the Division of Neurology at the Food and Drug Administration and has had this position for the past 10 years. She attended GWU Medical School and went on to do a Neurology Residency and a Stroke Fellowship at Georgetown University Hospital. During her Fellowship, she participated as a co-investigator in several clinical trials and became more interested in drug development and clinical trial design. She worked in private practice for several years at Kaiser Permanente and then as a Stroke Neurologist at Holy Cross Hospital. She joined FDA in 2008 as a Clinical Reviewer in the Division of Neurology and had this role for 6 years prior to getting her current position. During her time at the FDA she participated in putting together the curriculum and training for a joint NIH/FDA Fellowship in Clinical Trial Methodology and Regulatory Science.