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



Required and Additional reading

The document will be available before the start of the Module


Download eLearning week 6 module programme (pdf)