Primary source: Open Government Licence v3.0
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Sign in to saveHealthcare professionals must now adhere to a minimum distance of 100 meters between wireless CTG devices operating on the same RF channel to prevent signal crossover. Additionally, healthcare professionals are required to report any adverse incidents through the appropriate reporting channels.
These safety considerations are crucial to prevent patient misinterpretation of fetal heart rates due to signal crossover, which can lead to incorrect clinical decisions and adverse patient outcomes.
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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 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.
