SoHO Regulation - Overview and Impact - Online Training Recording
Regulatory framework, interfaces and practical implications
Course No. 23110
Speakers
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Roman Rolka
Quinta Analytica
Overview of the EU SoHO Regulation | Focus on regulatory consequences for donation, starting materials, quality management systems and critical interfaces between collection and manufacturing
Target Group
This seminar is aimed at professionals and managers from the pharmaceutical, biotechnology and blood/plasma sector who are involved in activities related to substances of human origin and who are affected by the implementation of the new EU SoHO Regulation. The programme is relevant for people with the following background:
Employees from Quality Assurance, Quality Management and Regulatory Affairs
Professionals from cell and gene therapy development and manufacturing
Staff from blood establishments and plasma collection centres
Manufacturing, process and technology Managers
Personnel involved in donation, collection, testing, import and export of SoHO materials
Project managers responsible for regulatory implementation and transition activities
Objectives
This seminar aims to provide participants with a clear understanding of the motivation, scope, and structure of the new EU SoHO Regulation. Participants will learn to correctly interpret key definitions, roles, and delineations within the SoHO framework. Participants will also gain insight into the regulatory impact on cell and gene therapies. This includes changes related to autologous and allogeneic donations, the use of SoHO as starting materials, and associated quality management system requirements. Additionally, the seminar will address the consequences for blood donation and plasma collection. There will be a particular focus on the regulatory interfaces between collection and manufacturing, as well as import and export requirements. The seminar will also address the opportunities and challenges that arise during the transition to the new regulatory requirements.
Background The European Union is introducing a harmonized and horizontal regulatory framework covering blood, plasma, cells, and tissues for the first time with the new Regulation on Substances of Human Origin (SoHO). The regulation aims to strengthen patient safety and the quality and security of the supply chain, while replacing the existing directive-based regulatory landscape.
After several years of legislative discussion and stakeholder consultation, the SoHO Regulation was formally adopted in 2024.It entered into force shortly thereafter, but its binding application will not take effect until 7 August 2027. This allows member states, competent authorities, and affected organizations sufficient time to adapt existing structures, processes, and quality systems to the new requirements. The regulation significantly impacts established processes, from donation and collection to the use of substances of human origin as starting materials for medicinal products, particularly for cell and gene therapies. Blood and plasma establishments will also be affected by new requirements, especially with regard to quality management systems, regulatory interfaces, and import and export activities.
While the transition period presents considerable challenges, it also offers opportunities for harmonization and optimization of processes across the EU. But what exactly is the impact on different areas? This seminar will answer this question and many others.
Programme
SoHO Regulation – The new Regulation on Substances of Human Origin
The motivation to create this EU Regulation
The Who’s Who of SoHO – Definitions and delineations
SoHO Regulation at a glance
SoHO Regulation: Impact on Blood Donation and Plasma Collection
Overview of the current situation in the EU
Interface between collection and manufacturing
Impact on import and export of Plasma
Opportunities and challenges during transition
SoHO Regulation: Impact on Cells & Gene Therapies
What will change for donation of cells / tissue for autologous use or allogeneic use
From SoHO to starting materials
QMS requirements for cell donation
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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