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Wytyczne dla przemysłu (Guidance for Industry) ICH Q8, Q9, Q10

Katedra i Zakład Technologii Leków i Biotechnologii Farmaceutycznej Warszawski Uniwersytet Medyczny. Wytyczne dla przemysłu (Guidance for Industry) ICH Q8, Q9, Q10. dr Piotr Ślifirski. CTD Common Technical Document. 1.0. Not part of the CTD. Moduł 1. Regional administrative

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Wytyczne dla przemysłu (Guidance for Industry) ICH Q8, Q9, Q10

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  1. Katedra i Zakład Technologii Leków i Biotechnologii FarmaceutycznejWarszawski Uniwersytet Medyczny Wytyczne dla przemysłu (Guidance for Industry) ICH Q8, Q9, Q10 dr Piotr Ślifirski

  2. CTD Common Technical Document 1.0 Not part of the CTD Moduł 1 Regional administrative information CTD table of contens 2.1 CTD Introduction 2.2 Moduł 2 CTD Nonclinical Overview 2.4 Clinical Overview 2.5 Qality Overall Summary 2.3 Nonclinical Summaries 2.6 Clinical Summaries 2.7 Moduł 4 Nonclinical Study Reports 4.0 Moduł 5 Clinical Study Report 5.0 MODUŁ 3 Quality 3.0

  3. Moduł 3 – Jakość (Quality)

  4. Moduł 3 – Jakość (Quality)Produkt leczniczy

  5. Moduł 3 – Jakość (Quality)Produkt leczniczy c.d.

  6. ICH The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

  7. ICH MedDRAMedical Dictionary for Regulatory Activities

  8. ICHWorking groups QSEM

  9. ICH Quality Guidelines

  10. Q1A-Q1FStability

  11. Q2Analytical Validation

  12. Q3A-Q3DImpurities

  13. Q4-Q4BPharmacopoeias

  14. Q5A-Q5EQuality of Biotechnological Products

  15. Q6A-Q6BSpecifications

  16. Q7Good Manufacturing Practice

  17. Q8Pharmaceutical Development

  18. Q9Quality Risk Management

  19. Q10Pharmaceutical Quality System

  20. Q11Development and Manufacture of Drug Substances

  21. ICH Q9QualityRisk Management • Link back to patient risk

  22. ICH Q9QualityRisk Management

  23. ICH Q9QualityRisk Management

  24. ICH Q9QualityRisk Management

  25. ICH Q9QualityRisk Management

  26. ICH Q10 Pharmaceutical Quality System (PQS)

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