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The new Regulation (EU) 2024/1938 on quality and safety requirements for substances of human origin (SoHO) intended for application on humans.

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
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