eCTD & CTD Preparation & Submission Course



Pharmaceutical eCTD & CTD Preparation & Submission, Structure of eCTD, 5 Modules, Practical software Demo, E-Validator


What you will learn

Basic Understanding of CTD & eCTD

Assisting in Compiling & filling and eCTD Application

Identifying EU & US Requirement for eCTD

5 modules of CTD and eCTD

Transiting from Paper based Submission to eCTD Submission

Review eCTD Application

General Demonstration of eCTD Software & eValidator

Regulatory affairs submission documents

Description

The eCTD specification has been developed to facilitate the Global electronic Submission, Review and Lifecycle management of medicinal product dossiers for regulatory applications.

*Complete the course as per your free time as life time access is available.

If you are paying more than 5k INR or $70 for private institute/academy then you are in loss.

Please compare the course description and amount you are paying for such course.

It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission.

If you are paying more than 5k INR or $15 for private institute/academy then you are in loss.

Please compare the course description and amount you are paying for such course.

The module provides a training and reference tool that will be of particular value to those new to the use of the format.


This online course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. This relatively fresh aspect of submissions will undergo significant and rapid changes as specifications are refined and modified further. This class is a superb training tool and reference and can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements.

Once all course requirements have been satisfied, a certificate of completion is immediately available.

Learning Outcome

  • Basic Understanding of CTD & eCTD
  • Assisting in Compiling & filling and eCTD Application
  • Identifying EU & US Requirement for eCTD
  • Transiting from Paper based Submission to eCTD Submission
  • Review eCTD Application

Course Structure

  • Introduction & Overview of CTD
  • CTD Fundamentals ( Module 1 – 5)
  • eCTD Fundamentals & Details
  • Best Practice in Preparing eCTD
  • Submission using eCTD Format
  • Life Cycle Management for eCTD
  • eCTD Software for Compilation & Validation

Who will Benefit ???

  • QC/QA Managers & Staff
  • Documentation Department
  • Regulatory Affairs Department – Responsible for CTD /DMF Preparation & Submission
  • Research Chemist, Quality Control Chemist, CRO’s involved in Documentation
  • Pharmacy Graduates with knowledge of CTD
  • Any science graduates who are seeking job opportunities in Regulatory Affairs

Teaching Methodology

  • Participants will be provided with course & study material
  • Practical Training will be provided on eCTD.
  • Paritcipants can ask their query/questions to the instructor during the course.

Benefits of Getting Certified then job opportunities as

  • Regulatory Affairs Associates
  • Regulatory Affairs Assistance
  • Regulatory Affairs Head/ Director
  • Medical Information Associates
  • Drug Inspector/Drug Controlle
  • Drug Safety Specialist/ Regulatory Food Safety Scientist
  • Quality Operations/Quality Control/Quality Assurance

Eligibility

  • Life Science Graduates with Experience or Knowledge of Regulatory Affairs
English
language

Content

Introduction

Introduction

Module 1 (Administrative part – Region Specific)

Module – 1 Administrative (Region Specific)

Module – 2 (Summary & Overview)

Module – 2 (Summary & Overview) Part -I

Module -3 (Quality)

Module -3 (Quality) Drug Substance
Module -3 (Quality) Drug product part – I
Module -3 (Quality) Drug product part – II
Module -3 (Quality) Drug product part – III
Stability Study

Module 4 (Non-Clinical Study)

Module 4 (Non-Clinical Study)

Module 5 (Clinical Study)

Module 5 Clinical Safety reports Part – I
Module 5 Clinical Safety reports Part – II

eCTD Structure (Template as per software)

Introduction to eCTD and Formatting
eCTD Structure

eCTD Software General demonstration

eCTD Software General demonstration

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