Pharmacovigilance for Cell and Gene Therapies

📢 DDReg Knowledge Capsule – Episode [13]This Podcast explains that because CGTs are transformative but complex, specialised pharmacovigilance (PV) is essential throughout the entire product lifecycle, from preclinical evaluation to long-term follow-up (LTFU), which can extend up to 15 years. The text outlines key components of PV, including risk assessment, clinical safety monitoring for events like cytokine release syndrome, and detailed Risk Management Plans (RMPs) for regulatory submissions. Furthermore, the source addresses limitations such as unpredictable immune responses and small patient cohorts, suggesting that emerging technologies like AI and blockchain are necessary to strengthen global safety surveillance and data traceability to comply with regulations from bodies like the FDA and EMA.https://resource.ddregpharma.com/blogs/pharmacovigilance-in-cell-gene-therapy-safety-challenges-beyond-the-science/