ICH Training Materials: Modules 0 – 9

Module 0 – Overview.pdf
Module 1 – Developing Acceptable Levels for Other Routes of Administration.pdf
Module 2 – Justification for Exceeding a PDE.pdf
Module 3 – Developing Acceptable Levels for EI not in Q3D.pdf
Module 4 – Considerations for Large Volume Parenterals.pdf
Module 5 – Risk Assessment.pdf
Module 6 – Controls on Elemental Impurities.pdf
Module 7 – Calculations Options.pdf
Module 8-1a – Case Study 1 for PQS_14Jul2016.pdf
Module 8-1b – Case Study 1 for Dossier_14Jul2016.pdf
Module 8-2 – Case Study 2 for PQS_August2016.pdf
Module 8-3 – Case Study 3 for PQS_14Jul2016.pdf
Module 9 – Consolidated FAQs final_14Jul2016.pdf

Dermal Draft guidance – October 2019