USP General Chapter 825 Updates

Course overview

Learning Objectives: At the completion of this activity, the participant will be able to: 1. Identify the key components in the radiopharmaceutical drug approval process from pre-clinical to human use 2. Recognize the different types of investigational new drug (IND) filings that can be used to initiate radiopharmaceutical clinical trials 3. Compare the different regulatory roles that are required during the drug approval process 4. Evaluate the roles and responsibilities of the radioactive drug research committee (RDRC) as part of the drug approval process 5. Describe the key steps that are required for submission and approval of new drug applications (NDAs) for new radiopharmaceutical drug products that have completed clinical trials NOTE: An annual subscription for Purdue's nuclear pharmacy re-certification program provides access to both the continuing education component of the program and the "Radiopharmacy Portal" a reference resource for practitioners. Subscriptions to the continuing educational offerings, which have been accredited through ACPE and BPS, can be purchased for an annual fee of $225 for nuclear pharmacists and $125 for nuclear pharmacy technicians.