Primary source: EMA - Regulatory and procedural guidelines RSS
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Sign in to saveThe updated INS-GCP-1 procedure clarifies and standardizes the coordination process for GCP inspections among EU/EEA inspectorates, detailings steps for both routine and for-cause inspections, and sets deadlines for inspections, with integrated reports due two weeks before Day 150 for routine inspections.
The new procedure enhances consistency in the GCP inspection process, which is crucial for ensuring compliance with safety standards across clinical trials conducted in Europe, and thus impacts regulatory readiness and the quality assurance processes of involved organizations.
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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 review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.
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.
