Aligning RWE & Regulatory Strategy From the Start to Build Submission-Ready Evidence & JCA Readiness
1:45 pm - Thursday 11th February 2027
- Explore why RWE submission planning needs to begin alongside regulatory strategy rather than being developed retrospectively once evidence gaps have already emerged
- Identify which RWE requirements, data sources and methodological considerations should be anticipated early to ensure evidence generated throughout development can support future submissions
- Assess how population differences, data quality and representativeness can affect algorithm performance across healthcare settings and create risks when models are transferred between populations
