Building the eCTD in Middle East - Practical Solutions to Compile Electronic Submissions
This course will offer insight into the compilation of eCTDs, share experience and best practice gained during eCTD submissions around the world, and explain the eCTD review and lifecycle process. Especially eCTD submissions in the GCC region and Jordan will be addressed in detail.
Participants are kindly requested to bring their laptops/electronic devices with them.
- Overview of eCTD readiness at the agencies
- Impact of the eCTD on regulatory processes and procedures
- Practical experience of submitting an eCTD in the EU and GCC
- eCTD compilation and life cycle management
- Document granularity and readiness
- Regulatory strategy facing technical issues
- Specifications and standards versus regions and procedures
- A global approach to electronic submissions
Who should attend?
Professionals working in:
- Regulatory Affairs
- Dossier Management
- Document Management
- Data Management
- Electronic Publishing/Submissions
- IT/IS EDMS
- Medical Writing
- Regulatory Affairs Agency eSubmission processing and review
At the conclusion of this course, participants will be able to:
- Participate in the preparation of the eCTD including creating “submission ready documents”
- Recognise eCTD requirements on a regional and ICH basis
- Discuss the processes and procedures of compiling and reviewing an eCTD
- Create and submit technically valid GCC eCTDs
- Prepare to move from a paper to eCTD process
- Describe technology used for eCTD compilation, validation and review
- Understand the difference between eCTD and NeeS submission
- Have an overview on future eSubmission development
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.