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
This course will bring professionals with no experience up to date on all aspects of electronic submission and will address US specific requirements as well as the status in the rest of the world and the future of eCTD. The course is technology and vendor neutral and will employ hands on use of basic software and internet use only. This offering will be taught by an industry expert in regulatory affairs and electronic submissions and who specializes in training and education.
Who Should Attend
This training course is designed for professionals working in regulatory operations and regulatory affairs, as well as for project managers, medical/technical writers, quality assurance and IT. This course content would also benefit professionals working in drug development and marketing authorization.
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