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Module 3 of the Global CTD

21 - 23 October 2019

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

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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