SIGHTSoHO
WEEKLY TRAINING MODULE 6
BTC preparation process authorisation
Schedule
03/03/2025 – 07/03/2025
Sub-topics
- A common approach on PPA (GAPP Guideline)
- Quality and safety assessment (product/process)
- Clinical assessment as part of PPA (risk-based)
Learning objectives
- To gain awareness on quality, safety and clinical efficacy of new preparation processes