TISSUE BLOOD

PROGRAM

The new guideline for the Application of Minimum Standards for the collection activities of therapeutic peripheral blood cells was released in June 2024.

The aim of the course is to:

a) Read the Guideline together

b) Define an interpretation method

c) Compare the document with the reference regulation (EDQM, Rep. acts 49/CSR, Rep. acts 29/CSR, JACIE Standard 8 edition)

d) Simulate a regulatory verification activity

- Presentation of Regulation (EU) 2024/1938
- Key differences compared to previous directives (2002/98/EC and 2004/23/EC)
- Main objectives of the regulation
- Quality requirements for SoHOs
- Security measures for donors and recipients
- Technical standards and guidelines to follow
- Registration and authorization of SoHO entities
- Surveillance and compliance
- Role of the competent authorities
- Traceability system for SoHOs
- Monitoring of clinical outcomes
- Recording and communication of data
- Import requirements
- Export procedures

Course Materials
- Copy of Regulation (EU) 2024/1938
- Presentation slides
- Additional reading material
- Certificate of participation

Objectives of the Course
- Provide a detailed understanding of Regulation (EU) 2024/1938
- Highlight the main responsibilities of SoHO entities
- Discuss best practices for ensuring the quality and safety of SoHO
- Facilitate preparation for the implementation of the new regulation

 Requirements for Participants
- Basic familiarity with healthcare regulations
- Experience in activities related to substances of human origin (preferable but not mandatory)