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Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier

23 - 25 January 2018

Radisson Blu Edwardian Grafton, London

This 3-day 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. This course will teach you how to:

  • Compile and submit Module 3 (CTD) of your registration dossier
  • Ensure that Module 3 (CTD) of your dossier contains all data needed
  • Achieve the quickest turnaround for your submission
  • Deal effectively with regulators

Become more confident in your daily practices after three days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your dossier.

This course is also available for studying online, check website for dates>>

  • Build Module 3 (CTD) of the dossier to meet regulatory requirements
  • Understand the legal framework and guidelines for the CMC/Quality part of the dossier
  • Meet the legal responsibilities of the manufacturing authorisation holder, and the designated qualified person
  • Write the application with a view to product maintenance and consistent supply
  • Define the impact of the Common Technical Document on the Quality section of the dossier
  • Write variation submissions for Europe and get approval first time
  • Structure your submission teams to ensure compliance
  • Link your dossier requirements to GMP
  • Minimise delays in your submission by providing accurate documentation
  • Use certificate of suitability as replacement of data

Andrew Willis has over 28 years' of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.

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

Very useful, interactive course with a practical approach!


Regulatory Affairs Specialist, Labesfal-Fresenius Kabi

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