Insight Into Quality Requirements & Regional Regulatory Variability Impacting Radioligand Therapy (RLT) & Radioligand imaging (RLI) Products from Clinical to Commercial Phase
- Differentiating kit for radiopharmaceutical preparation from ready to use solutions for injection/infusion
- Overview of guidelines to be followed for dossier preparation
- Control strategy, where to start? Control of chemical and radioactive precursors
- Building up the information/data for submission from clinical to commercial stages