As part of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the reauthorization of the Prescription Drug User Fee Act (PDUFA V), there will soon be a mandate for the use of electronic submissions, specifically the electronic common technical document (eCTD) in the US. There already exists a mandate in Europe for marketing applications that are eligible for Centralized Procedure review. Electronic submissions are accepted globally in various formats and there are well established standards being used for their creation.
This course will focus on the technical foundations of electronic submissions and their use as well as the practicalities and processes of creating them. The use of technology and the specifications needed for various types of submissions will be presented along with common issues and challenges. The US requirement for the submission of datasets will also be addressed.
Examples of how standards can be employed to generate and track applications will be discussed, and activities on locating current guidance and submission metadata will all be part of this interactive course.
Course Level: Beginner
eSub/eCTD Guidance, vocabulary and terminology, document and data standards, mapping from regulation to submission
What you will learn
Who should attend?
At the conclusion of this activity, participants should be able to:
- Describe the technologies that make up the foundation of electronic submissions
- Recognize document and data standards and how to apply them
- Identify electronic submissions by region and type
- Use eCTD and eSUB vocabulary with ease and confidence
- Discuss the structure of CTD/eCTD and the required content
- Identify process change and change management needs