Primary source: Open Government Licence v3.0
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Sign in to saveA consultation has begun to evaluate and potentially revise the performance standards for local bus services, specifically concerning punctuality and reliability metrics. This includes reassessing the longstanding expectation that 95% of services operate within a window of one minute early to five minutes late.
This consultation could lead to new regulatory expectations affecting compliance and performance assessment for local bus services. With technological advances and evolving industry practices, it's essential for stakeholders to contribute their views to ensure relevant and effective guidance.
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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.
