[SK1-1] US GMP PET Drug Production
Sally Schwarz is a Professor of Radiology at Washington University School of Medicine in St. Louis. She is a Board Certified Nuclear Pharmacist. She has developed and managed the PET Production of PET Radiopharmaceuticals for clinical and clinical research use for over 20 years, established the first PET Nuclear Pharmacy at Washington University in St. Louis, and has been involved in training pharmacy students as part of the PharmD program at St. Louis College of Pharmacy and the University of New Mexico. She served on the USP Expert Committee for 10 years, and was involved in writing the revised USP Chapter <823> which defined the GMP PET production and quality control requirements for PET radiopharmaceuticals for research use. She is the Secretary of the Radioactive Research Committee at Washington University Medical School. She has recognized expertise in preparation of the Chemistry Manufacturing and Control documents, including production and quality control for Investigational New Drugs (INDs and RDRC Applications. She is a member of the American Pharmacist Association (APhA), and the APhA Nuclear Pharmacy SIG. Sally became an APhA fellow in 2009, and received the William H. Briner Distinguished Achievement Award at the APhA meeting in March 2016. She served as the Nuclear Pharmacy advocate on the NRC Advisory Committee for the Medical Use of Isotopes (ACMUI) for 6 years. She also served on the Certification Board of Nuclear Cardiology for 6 years. Sally has been a member of the Society of Nuclear Medicine and Molecular Imaging for 30 years, and is currently the President of the SNMMI. Sally and is the first pharmacist, and 4 th woman of 64 SNMMI Presidents to hold this position.
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