What’s New in the SoHO Regulation
What operators and distributors of substances of human origin need to know!
Substances of human origin (SoHO) — such as blood, blood components, tissue or gut microbiota — will be uniformly regulated by EU regulation EC/2024/1938. The effective date of the German version of the SoHO regulation is August 7, 2027. The increasingly clear requirements pose a challenge and are the reason for our webinar.
🤔 Why should I participate?
To smooth the transition to the future regulatory requirements. And to ensure SoHO compliance through early planning of necessary resources in key positions and targeted adaptation of the (pharmaceutical) quality system. Our experts will provide you with comprehensive information!
👭Who should participate?
Managers from blood donation services, tissue banks, fertility centres, and manufacturers/suppliers of ATMPs using human starting materials. Additionally, everyone who is interested in the topic.
🔎 Our GMP experts provide you with an overview of the emerging regulatory SoHO challenges and show promising implementation strategies.
✅ Agenda
- Welcome & personal introduction
- Regulatory overview (EC/2024/1938) — scope, timeline, transition period (entry into force 07/08/2027 + 1 year)
- Practical requirements — quality systems, staffing and ATMP relevance
- Specific recommendations and next steps
- Q&A and discussion
Presenter: Dr. Tom Teichman, GMP consultant specializing in GMP for cell and gene therapy.
🥇 Gain an early understanding about the requirements of the German version of the SoHO regulation, EC/2024/1938, and an effective implementation strategie.
📍 Location: online via Teams
📆 Date: September 3 and 17, 2026, 11:00-11:45 am CET (incl. Q&A)
🌐 Language: English
Participation via the registration form.
The SoHO regulation has far‑reaching consequences for stakeholders handling substances of human origin. Early adjustments to quality systems and targeted staffing plans reduce risk and ease the transition.
Reserve your place in the webinar now!
Please register here: