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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.

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.

PV teams should update workflows and standard operating procedures (SOPs) to incorporate these clarified dossier requirements. Ensure that all biological product dossiers include necessary details as outlined by the new guidance and provide training to relevant staff on these changes.

PV teams should review and update Standard Operating Procedures (SOPs) to align with new EMA guidelines on data management, accessibility, and sharing. Ensure compliance with the security standards outlined by the EMA to protect sensitive data and maintain data integrity.

PV teams should update SOPs related to inspection readiness and regulatory intelligence monitoring to align with the new coordination steps and deadlines mandated in the INS-GCP-1 procedure.

PV teams must update workflows and SOPs to include the requirement of contacting member state contact points prior to the launch of QR code content, specifically when it contains non-statutory information.

Update workflows and SOPs to incorporate the new biowaiver criteria, particularly in regulatory filing processes for applications involving additional strengths of solid oral dosage forms.

PV teams need to update SOPs and workflows related to user safety risk assessments and ensure that procedures are aligned with the new draft guidelines prior to its implementation following the consultation.

PV teams must engage in the public consultation by preparing comments on the draft guideline. Additionally, update any related SOPs and compliance controls to align with the new structured signal management framework once finalized.

PV teams must ensure that their workflows, SOPs, and compliance controls are updated to reflect the new pharmacovigilance recommendations issued by the EMA for 2026. Attention should be given to the monthly updates for product-specific implications.

PV teams must review and update their workflows related to regulatory intelligence monitoring to align with the new PMF submission timelines and ensure compliance with upcoming guidelines specified in the 3-year work plan.

Update workflows and SOPs related to Country Compliance and PMF submission processes to ensure timely response to the newly defined 60-day timelines.

PV teams should update their Standard Operating Procedures (SOPs) related to QT/QTc evaluation methods, integrate new assessment frameworks based on the revised guidelines, and consider the necessity for training on these updates.

PV teams must update their workflows and SOPs to align with the new PSUR requirements, increasing the frequency and detail of safety monitoring and adverse event reporting. Staff training may be necessary to ensure compliance with these changes.

PV teams should update workflows related to Inspection Readiness and adjust compliance controls to emphasize reliance on inter-authority inspections as part of their preparation strategies.

PV teams must revise SOPs for inspection readiness to incorporate increased collaboration and risk-based planning protocols, ensuring that workflows align with the new inspection resource allocation strategies.

PV teams must update their SOPs to incorporate new timelines and reporting requirements related to PSUSAs. Ensure workflows related to regulatory intelligence and signal management are aligned with the new EMA guidelines to maintain compliance.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.