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Preparing the Quality Module of the CTD

5-week online course | 2 hours per week

Next intake begins 4 March 2019

Online Academy

The Quality and Pharmaceutical Module (Module 3) of the CTD is challenging and requires considerable expertise to comfortably manage it. 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.

This course will teach you how to:

  • Complete and submit Module 3 (CTD) of your registration dossier
  • Ensure the correct structure is achieved for Module 3 (CTD)
  • Achieve the quickest turnaround for your submission
  • Deal effectively with regulators 

Over 5 weeks, completing 2 modules per week, become confident compiling the Quality and Pharmaceutical section of your dossier.

100% of people surveyed who took this course found it beneficial to them in their day-to-day role.

This course is also available as a public training course - check the website for dates>>

What is an Online Academy course? 

Online Academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 

 

Over 5 weeks students will learn through:

  • 10 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 5 weeks the course is running
  • Additional content such as materials and white papers available to download

Sumaiya Patel
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.


Sophie Nageotte Hennion
Sophie has over 18 years of experience in the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and then went on to work in regulatory compliance in companies such as Bayer, Stragen, PregLem and Laboratoires Galderma. She now runs her own consultancy, delivering consultancy and training as a regulatory CMC expert for pharmaceuticals and food supplements. Her specialty areas are CTD Module 3 and QOS writing, variations, lifecycle management and answering questions from health authorities.


  • Compile and submit the Quality and Pharmaceutical section of your registration dossier
  • Ensure all data needed has been collected
  • Ensure suitability of data from your development and manufacturing groups
  • Deal effectively with Regulators: Meeting the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
  • Understand the regulatory legal framework and influences on your Module 3 style

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

The trainers for the course were very friendly and clearly very knowledgeable. I found the flexibility of the course and the structure very useful to fit around my schedule.

Regulatory Affairs specialist, Liqvor CJSC


What happens during an Online Academy course?

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Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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