Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018 is a course that covers topics such as:
- Impact of the eCTD on regulatory processes and procedures
- Overview of eCTD readiness at the agencies
- ECTD compilation and life cycle management
- Practical experience of submitting an eCTD in the EU and GCC
- Regulatory strategy facing technical issues
- Document granularity and readiness
- Specifications and standards versus regions and procedures
Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018 brings together attendees with responsibilities in:
- Dossier Management
- Regulatory Affairs
- Data Management
- Document Management
- Electronic Publishing/Submissions
- Compliance
- Medical Writing
- IT/IS EDMS
- Regulatory Affairs Agency eSubmission processing and review