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الرئيسية Uncategorized Common Technical Document (CTD) for Registration of Human Drugs Online Training Course
Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
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Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
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Common Technical Document (CTD) for Registration of Human Drugs Online Training Course

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COURSE AGENDA
Introduction 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)

MODULE 1
Administrative 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

MODULE 2
Requirements of the summaries and Overview documents

·QUALITY overall summary (QOS)

·Non-Clinical SUMMARY AND TABULATE Summaries

·Non-clinical Overview

·Clinical overview

MODULE 3
Understanding 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

MODULE 4

Non-Clinical Study Reports

MODULE 5
Clinical Study Reports

·Clinical data requirements for efficacy and safety

·Clinical summary

·Bioequivalence

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