WEEKLY TRAINING MODULE 6

BTC preparation process authorisation

 

 

Schedule

03/03/2025 – 07/03/2025



Sub-topics

  • A common approach on PPA (a focus on Technical Annexes of the GAPP Guideline for PPA)
  • 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

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