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2021 ISPE Aseptic Conference

VL21CEMAR1/SES111 - Regulatory View on ATMPs and Make vs. Buy


Mar 17, 2021 9:00am ‐ Mar 17, 2021 10:00am


Description

Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs will be the topics during this ATMP Session. Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. Interview with Alyce Maksoud TGA (Therapeutic Goods Administration from Australia) and Francesco Cicirello Adaptimmune (former TGA Subject Matter Expert): Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. Alyce Maksoud, Team Leader Inspection Section, TGA MQB Australian Department of Health, PIC/S Chair of the Working Group on Tissue and Cells. The Interview with Alyce and Francesco will cover most ask questions related to Cell and Tissue Manufacturing. A must to attend for all working with ATMPs.

Session Leader(s):

  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

Speaker(s):

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