Common Technical Document (CTD & eCTD) for Registration of Human Drugs Online Training Course

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

What is eCTD, how it differs from CTD, XML backbone, folder structure