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Preparing the Quality Module of the CTD

5-week online course | 2 hours per week

5 October - 9 November 2020

Online Academy

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 practice to complete the Module faster and overcome regulators' questions to fast track submission times and get your products to market quickly.  

This course is also available as a live online academy - check the website for dates>>

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing [email protected] and we will arrange this for you as soon as possible.

  • 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

Sophie Nageotte

Sophie has over 20 years of experience in the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, Stragen, PregLem and Laboratoires Galderma. She gained a strong experience in the worldwide regulatory environment for the manufacture and control of the medicines.

She now runs her own consultancy, delivering consultancy and support in writing IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities.

Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.

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

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.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Download the digital training guide.

 

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


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