Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Scientific guideline
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.
Keywords: Guideline on safety and efficacy, follow-up - risk management of advanced therapy medicinal products (ATMPs)