WORK PACKAGE ARCHITECTURE

Context

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