The Radiopharmaceutical Oversight Committee (RPOC) is not required by any regulatory organization. However, University of Colorado Denver Administration believes that the RPOC will provide assistance and support to the radiochemist and the C-TRIC in order to ensure effective, successful, and compliant operation. The RPOC will also generate reports for review by other University committees with regulatory oversight. RPOC membership shall include a: Pharmacist, Board Certified Nuclear Medicine Physician, Chemist, and Radiation Safety Officer (RSO), to include representatives from: C-TRIC, Radiology, School of Pharmacy, and the Combined Institutional Review Board (COMIRB).
RPOC Activities Include:
- Oversight of policies and procedures used to ensure compliance with the rules and regulations governing the production and formulation of radiopharmaceuticals (i.e. PET drug). UCD RPOC limits PET drug and PET drug product production for investigational and research use only:
- Investigational PET drugs or drug products for human use produced under and Investigational New Drug (IND) application in accordance with 21 CFR Part 312.
- Research PET drugs or drug products produced with approval of a Radioactive Drug Research Committee (RDRC) in accordance with 21 CFR Part 361.1. [The regulatory requirement to follow current good manufacturing practice is met by producing PET drugs in accordance with established policies and procedures that conform with USP Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography-Compounding.]
- Oversight of staffing, maintenance, and usage of the cyclotron including determining priority of use in situations where there are competing requests.
- Review of internal and external audit reports that relate to the production or compounding of radiopharmaceuticals.
- Review of adverse events or unanticipated problems that may relate to the production or compounding of radiopharmaceuticals.
The RPOC will meet quarterly, or as often as necessary, at the discretion of the Committee Chair.
If you have any questions, please contact the RPOC Coordinator at 303-724-4743