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Advanced Therapy Medicinal Products (ATMPs) are already marketed in international markets and in many cases lack specific regulation. As a consequence, existing requirements used for traditional biological products may be applied without acknowledging the specific considerations for these new therapies. This presentation will focus on ATMP specific characteristics, where compliance to existing GMP frameworks may prove challenging, and review current ATMP specific GMP guidances.
Speaker(s):
Jasna
Curak,
Global Quality and External Collaboration Manager At Roche,
F. Hoffmann La Roche Ltd
Credits
Credits: None available.
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