From Bench to Batch: Operational Readiness for ATMPs in the New Regulatory Era
Time: 2:15 pm
day: Conference Day One
Details:
- Examine how the EMA’s 2025 Guidance on ATMPs and the FDA’s June 2025 – Roundtable are reshaping expectations across both research and GMP environments in cell and gene therapy
- Explore practical strategies for aligning with evolving regulatory demands, including structured data capture, end-to-end traceability, bi-directional cell and reagent lineage tracking, electronic batch records, and real-time quality oversight
- Gain a roadmap for regulatory alignment and future-proofing ATMP operations – whether building autologous therapies or scaling allogeneic platforms
