During this webinar you will learn how to effectively prepare for a compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.
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点播网络研讨会Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, CMC, quality, and clinical planning. Reducing risk, avoiding delays, and staying inspection-ready without overbuilding internal structures.
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点播网络研讨会In this free workshop, Filip, together with Andrea Di Luca, Ph.D. in Regenerative medicine and Team Leader of the ATMP core team at QbD, and Evan Claes, expert in the application of Quality-by-Design principles, will explain the basic concepts of QbD methodology and showcase a practical case.
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点播网络研讨会The webinar discusses the evolving pharmacovigilance and risk management environment of innovative therapies, emphasizing safety challenges in cell, CAR T, and RNA-based treatments, as well as gaps in regulation and surveillance strategies. Participants will gain insight into the origin and impact of safety concerns in these therapies, alongside ongoing developments in RNA-based treatments.
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