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Starting 13-15 September 2022
LIVE Online Course | 9am – 5pm CET
Starting 13-15 September 2022

LIVE Online Course | 9am – 5pm CET

Navigate through the complex requirements of Module 3 of the Global CTD

Understand what data is required in module 3 and brainstorm common challenges and solutions for faster dossier 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 Training Course

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
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
  • 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 two days prior to the course start date. If you have any questions please contact felicity.bell@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.