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Standards of Care


Gene and cellular therapies are inherently complex products and treatment administration is restricted to qualified centres. With the rapid developments and pending product approvals, there is a need for developing treatment guidelines and harmonising centre qualification procedures across pharmaceutical companies, accreditation bodies and national requirements.

Overall aims: 

  1. To develop harmonised guidelines on patient and product management for health care professionals.
  2. To reduce inspection burden and redundancies by developing and implementing consensus-driven requirements and qualification standards for clinical teams delivering gene and cellular therapies from cells and tissues of hematopoietic origin.

Current work groups/activities: 

  • Harmonise centre qualification strategies by leveraging the JACIE qualification scheme
  • Harmonise labelling, documentation and packaging requirements
  • Develop guidelines on patient and product management, topics of interest include:
    • Guidance for hospital pharmacy on the implementation and operational management of CAR T-cell therapies
    • Recommendation guidelines on apheresis for ATMP manufacture