eCTD & CTD Preparation & Submission Course

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

What you'll 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
Requirements
Bachelor of Pharmacy Students
Pharmacy PG Diploma
Pharmacy Background
Medical Science background
Curiousity about learning
Pharma professionals
Industrial professionals
Bachelor's of pharmacy students
Research scientist
Research associates
Pharmacy educational students
Regulatory affairs career
New opportunity looking professionals
Regulatory department professionals
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

Who this course is for
Pharmacy Graduates Students
Science graduates
Master of Pharmacy Students
Pharmacy PG Diploma
Diploma Pharmacy Students
Medical Students
Clinical Pharmacy Students
Pharma Professional