We want to connect, learn from and work with you.
WORK PACKAGE ARCHITECTURE
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.
- To develop harmonised guidelines on patient and product management for health care professionals.
- 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