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Informa
Starting TBC in 2021

5-week online academy

Learn to analyse, prepare and construct the intricate details of Module 3 of your dossier to ensure a more efficient submission process

Course Overview

The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is arguably the most challenging aspect of regulatory approval and requires considerable expertise to navigate it successfully. This detailed, 10 module course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 of your application and will show you how to compile this important part of your submission dossier.
 
Once completed you will have the skill and confidence to complete the Module 3 section of the CTD, and ensure the correct structure is maintained enabling you to work more effectively with regulators. Importantly, you will learn best practices to complete the Module faster and overcome regulators' questions to fast track submission times and get your products to market quickly.  

Online Academies

Pharmaceutical Training International online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 5 weeks students will learn through:

  • 10 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Dossier Submission
Dossier Submission

Compile and submit the Quality and Pharmaceutical section of your registration dossier

Data Requirements
Data Requirements

Ensure all data needed has been collected and is suitable for development and manufacturing groups

Regulatory Expectations
Regulatory Expectations

Deal effectively with Regulators: Meeting the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP


Quality by Design
Quality by Design

Incorporate Quality by Design into your CTD requirements and create the optimal Module 3

Regulatory Landscape
Regulatory Landscape

Understand the regulatory legal framework and influences on your Module 3 style

Dossier Compilation
Dossier Compilation

Build Module 3 (CTD) of the dossier to meet regulatory requirements


Legal Structure
Legal Structure

Know the legal framework and guidelines for the CMC/Quality part of the dossier

Who is this course for?

This course has been specifically designed to address the needs of:

  • Regulatory Affairs Managers/ Officers/ Assistants
  • Compliance Managers
  • Documentation Managers
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Qualified Persons
  • Key contributors to the submission package

Find out more about online academies...


PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.