SIGHTSoHO
WEEKLY TRAINING MODULE 1
EU legal provisions
Schedule
27/01/2025 – 31/01/2025
Sub-topics
- EU current directives and introduction to the new regulation;
- Basic information on current Medical Device Regulations relevant for Blood, Tissue & Cells (BTC) establishments;
- Bridges between Substances of Human Origin (SoHO), Advanced Therapy Medicinal Products (ATMPs) and Medical Devices frameworks.
Learning objectives
- To facilitate a harmonised interpretation of the EU legislative framework (transitional period);
- To deepen awareness of the connection and interaction of SoHO legal provisions with medical devices, ATMP and medicinal products legislation and their impact on inspections and authorisation of novel processes.