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Regulatory framework for ATMPs as described in Eudralex Volume IV Part IV - GMP requirements for Advanced Therapy Medicinal Products and the PIC/S Annex 2A. What are the expectations of EU GMP Inspections in the field of ATMP manufacture and the manufacture of viral vectors. Do we need further detailed guidelines or can every new innovation be covered by existing framework and quality risk management approaches.
Speaker(s):
Christina
Meissner,
GMP Inspector,
AGES - Austrian Agency for Health and Food Safety
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