eCTD & CTD Preparation & Submission Course

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Offered byUDEMY

eCTD & CTD Preparation & Submission Course
at
UDEMY
Overview

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

Duration	4 hours
Total fee	₹649
Mode of learning	Online
Credential	Certificate

eCTD & CTD Preparation & Submission Course
at
UDEMY
Highlights

Earn a certificate of completion from Udemy
Learn from 4 downloadable resources
Get full lifetime access of the course material
Comes with 30 days money back guarantee

eCTD & CTD Preparation & Submission Course
at
UDEMY
Course details

Who should do this course?

For Pharmacy Graduates Students
For Science graduates
For Master of Pharmacy Students
For Pharmacy PG Diploma
For Diploma Pharmacy Students
For Medical Students
For Clinical Pharmacy Students
For Pharma Professional

What are the course deliverables?

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

More about this course

The eCTD specification has been developed to facilitate the Global electronic Submission, Review and Lifecycle management of medicinal product dossiers for regulatory applications
his module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission
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

eCTD & CTD Preparation & Submission Course
at
UDEMY
Curriculum

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 & CTD Preparation & Submission Course
at
UDEMY
Faculty details

Mahesh Pratapwar

He is a Pharma Professional, having skill of Pharmaceutical Product development and Complying with Regulatory Specifications for Pharmaceutical products according to guidelines of US/Europe/CDSCO.