Identifying and managing safety concerns, implementing risk minimization measures (RMMs), and maintaining a structured risk-minimization system are crucial for ensuring patient safety throughout a product’s life cycle. Specific medicinal products may need additional risk-minimization measures (aRMMs) to address significant safety concerns that standard measures cannot fully manage, thereby enhancing their risk–benefit profile.
APCER Life Sciences offers comprehensive support in all aspects of risk management, including implementation, tracking, assessment, and modification of risk-management systems.