Introduction to this course: 

Find out the intricacies of compiling an electronic Common Technical Document (eCTD) for pharmaceutical marketing authorizations. Understand the structure, modules, and guidelines for efficient and standardized regulatory submissions. Dive into detailed content, from administrative forms to clinical data, and enhance your expertise in regulatory affairs. 

Who should attend: 

This course is ideal for regulatory affairs professionals, pharmaceutical company professionals involved in submission processes, quality assurance specialists, clinical research professionals, and anyone seeking to enhance their understanding of the eCTD structure and content for pharmaceutical marketing authorizations.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify and recall the components and structure of the electronic Common Technical Document (eCTD).

• Explain the purpose and content of each module within the eCTD.

What will I gain: 

Participants will gain enhanced expertise in compiling and organizing eCTD submissions, ensuring regulatory compliance and efficiency in pharmaceutical marketing authorizations.

Prerequisites: 

Prerequisites for this course include basic knowledge of regulatory affairs and familiarity with pharmaceutical documentation processes.

Additional information: 

Course duration: 00:25:03

Course code/version (effective date): L-156/v1.0 (27/03/2024)