• 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
  

This course will benefit professionals working in:

• Regulatory Affairs
• Dossier Management
• Document Management
• Data Management
• Compliance
• 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 “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.