Qualified Treatment Centres in APS
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We would like to create a rep email that directs referring physician to the qualified treatment centre (QTC) in their region for a specific therapy. Does PAAB require a DOF or another reference about the name of these centres? Could the list include ones that are in the process of approval as a QTC but not yet approved to avoid having to update the APS as each one comes aboard? The manufacturer would not select any QTC for the email until it is approved.
Thank you. -
We would like to create a rep email that directs referring physician to the qualified treatment centre (QTC) in their region for a specific therapy. Does PAAB require a DOF or another reference about the name of these centres? Could the list include ones that are in the process of approval as a QTC but not yet approved to avoid having to update the APS as each one comes aboard? The manufacturer would not select any QTC for the email until it is approved.
Thank you.Hello @jennifer_cm
An attestation letter from Med/Reg confirming that only sites which have been approved will be listed is sufficient. When submitting, provide a standardized template of how the sites will be listed. This will allow sites to be added and removed without a need to re-review as this becomes an administrative feature.
