COURSE AGENDAIntroduction to the Common Technical Document (CTD)And ICH·Overview On Regulatory Affairs System ·Background On the ICH Guidance And CTD ·Outline & basic Structure of CTD (Modules 1-5) |
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MODULE 1Administrative and Product Information·Outline of the contents of Module 1 ·Tables of contents ·The summary OF Product Characteristics (SPC) ·Packaging, Labelling and PIL regulations ·Certificates Requirements |
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MODULE 2Requirements of the summaries and Overview documents·QUALITY overall summary (QOS) ·Non-Clinical SUMMARY AND TABULATE Summaries ·Non-clinical Overview ·Clinical overview |
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MODULE 3Understanding Drug Substance:·Starting AND The material in A CHEMICAL SYNTHESIS ·Data provision options for manufacturing and control including Master Files and Certificates of Suitability Understanding drug substance:·Control of drug substance ·Stability ·Common deficiencies Understanding Drug Products·Starting and other materials in drug formulation ·Pharmaceutical development: composition, functions, optimization & bioequivalence ·Manufacturing process ·In-process and finished product control Understanding Drug Products·Control of drug products ·Stability ·Common deficiencies |
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MODULE 4Non-Clinical Study Reports |
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MODULE 5Clinical Study Reports·Clinical data requirements for efficacy and safety ·Clinical summary ·Bioequivalence |
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Common Technical Document (CTD) for Registration of Human Drugs Online Training Course
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