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Training_package_Module_0-9

Guidelines on pre-market approvals requirements-

Module 0 - Overview

Module 1 - Developing Acceptable Levels for Other Routes of Administration

Module 2 - Justification for Exceeding a PDE

Module 3 - Developing Acceptable Levels for EI not in Q3D

Module 4 - Considerations for Large Volume Parenterals

Module 5 - Risk Assessment

Module 6 - Controls on Elemental Impurities

Module 7 - Calculations Options

Module 8-1a - Case Study 1 for PQS_03Jul2018

Module 8-1b - Case Study 1 for Dossier_14Jul2016

Module 8-2 - Case Study 2 for PQS_August2016

Module 8-3 - Case Study 3 for PQS_14Jul2016

Module 9 - Consolidated FAQs final_14Jul2016

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