How can ATMP developers effectively manage long-term follow-up requirements for regulatory approval? With many ATMPs requiring post-market surveillance for up to 15 years., what are the best practices for patient monitoring, data collection, and regulatory compliance?
Lourens Bloem and colleagues have published an open access report on regulatory, scientific, and operational requirements and considerations for such Long Term Follow-up studies to facilitate generation of robust real-world evidence. Long-term follow-up after authorization of gene therapy: leveraging real-world data - ScienceDirect @Simone do you have suggestions where to find more guidance on this subject?