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2022 ISPE Europe Annual Conference

EU22CEAPR1/SES204 - Innovations in ATMPs and the Regulatory Framework


Apr 27, 2022 9:10am ‐ Apr 27, 2022 9:50am


Description

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):

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