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Sign in to saveThe recent workshop highlighted the need for improved strategies in collecting real-world data, aligning with new guidance as defined in the Data Quality Framework for EU medicines regulation. It emphasized the importance of collaboration among various stakeholders to address the shortcomings in current data collection practices.
As regulatory expectations evolve, organizations must adapt their data collection methods to ensure compliance with emerging standards. This workshop serves as a precursor to potential updates in regulations concerning the quality and utilization of real-world data, which could significantly impact regulatory submissions and assessments.
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PV teams should update workflows and SOPs to include the new section 19A approval processes and ensure compliance with the TGA's guidelines for managing medicine shortages.
PV teams should update their workflows regarding inspection readiness, review standard operating procedures (SOPs) to align with the new GCP inspection coordination processes, and ensure that all relevant personnel are trained on the updated guidance.
PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.
Update workflows related to regulatory intelligence monitoring and ensure that all relevant SOPs reflect the new guidelines on clinical requirements for sickle cell disease treatments.
