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PQS Effectiveness, ICH Q9(R1) & Using the CMC Regulatory Tools of ICH Q12 – a European Regulator’s Perspective

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Speaker Presentation: CMC Strategy Forum Japan 2025
O'Donnell Kevin, Health Products Regulatory Authority (HPRA) Ireland, 2025
PQS Effectiveness, ICH Q9(R1) & Using the CMC Regulatory Tools of ICH Q12 – a European Regulator’s Perspective

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