The new Regulation (EU) 2024/1938 on quality and safety requirements for substances of human origin (SoHO) intended for application on humans.
- 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)
Event information
Event Date | 25-10-2024 14:00 |
Event End Date | 25-10-2024 18:00 |
Cut Off Date | 25-10-2024 12:00 |
Individual Price | 150 + VAT 22% |
Location | Webinars - Online |
Category | TISSUE BLOOD, Continuing Education |