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Module 3 of the Global CTD

9 - 18 June 2020

New LIVE Online Academy

LIVE ONLINE ACADEMIES

In light of the uncertain times we’re facing at the moment, 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, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact [email protected].

For more information and a comparison with other digital study modes, download the digital training guide.

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 skill to minimise delays. 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.  
 
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.  

  • 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

Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

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

Regulatory Affairs Manager, Fresenius Kabi


Getting a deeper knowledge about 3.2. in Module 3 of the CTD was great. It was also good to be able to discuss with colleagues from other functions as well as with the trainer.

Regulatory Affairs Specialist, Fresenius Kabi


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