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GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceuticalcompanies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations.
International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).
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