FDA/CDER/OC/OSI/DCCE
Silver Spring, MD
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation (DCCE) and provides leadership and subject matter expertise on policy issues related to good clinical practice, human subject protection, and clinical trial quality. She also serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.
Before stepping into the position of Associate Director of Clinical Policy, Dr. Grandinetti was a senior reviewer in the DCCE’s Good Clinical Practice Assessment Branch from 2018 to 2024 where she provided regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and to FDA field investigators. Prior to joining the Office of Scientific Investigations, she served as a technical lead in CDER’s Office of Medical Policy (OMP) for approximately 8 years where she led the development of several guidances related to clinical trials, covering topics such as using electronic informed consent, electronic health record data, and electronic systems and electronic records in clinical trials.
She received her Doctor of Pharmacy degree from Virginia Commonwealth University in 2000 and her Bachelor of Pharmacy degree from West Virginia University in 1988. Prior to joining FDA in 2009, she worked as a Senior Clinical Research Pharmacist at the National Cancer Institute from 2002 to 2009 and as clinical pharmacist at the University of Virginia from 1988 to 2002.
Wednesday, November 20, 2024
8:45 AM – 10:00 AM PT