Long term follow up

Long term follow up

A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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31.03.2021

EMA Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products

The guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products.
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27.02.2023

SOP: CAR-T therapy discharge and follow up. CAR-T service pathway – post infusion

SOP for safe discharge and follow-up for patients, post Chimeric Antigen Receptor (CAR) T-cell therapy infusion.
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