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Starting 25-27 October 2021
LIVE Online Academy | 9am – 5pm BST
Starting 25-27 October 2021

LIVE Online Academy | 9am – 5pm BST

Learn how to compile this important section of your dossier to ensure faster turnarounds of submissions

Course Overview

The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is a critical element of the submission process and must be navigated with the skill to minimise delays. This course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application and will show you how to compile this important part of your submission dossier.  
 
Through presentations and discussion sessions you will become confident at compiling the chemistry and pharmacy section of your dossier, ensuring your dossier contains all the relevant data needed. You will also develop skills enabling you to submit the Module 3 quickly, speeding up the overall submission and approval process.  

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.

Students will learn through:

  • Live interactive sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

Learning Objectives

Module 3

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

The legal framework

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

Compliance

Meet the legal responsibilities of the manufacturing authorisation holder, and the designated qualified person

Efficient submissions and approvals

Write variation submissions for Europe and get approval first time

Team structure

Structure your submission teams to ensure compliance

Good Manufacturing Practice (GMP)

Link your dossier requirements to GMP

Certificate of Suitability (CEP)

Use certificate of suitability as replacement of data

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

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.

Regulatory Affairs

Manager

Fresenius Kabi

Very useful information and tips. The course was interesting and useful as we worked with specific topics/questions in groups.

Delegates of our live online academies said...

94%

would attend another live online academy

97%

found the course beneficial to their day to day role

97%

would recommend the course to others