SIGHTSoHO
WEEKLY TRAINING MODULE 1
EU legal provisions
Schedule
27/11/2023 – 01/12/2023
Sub-topics
- EU current directives and introduction to the new regulation;
- Basic information on current Medical Device Regulations relevant for Blood, Tissue & Cells establishments (BTC) and defining the borderlines for novel BTC with other regulatory frameworks, in particular where medicinal products and medical devices are concerned;
- Overlaps 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;
- 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.