Be aware of new legal requirements! The EMA recently published a revision of the roadmap for electronic submissions making eCTD submissions mandatory by January 2010.
This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically.
- 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
- eCTD compilation and life cycle
- Document granularity and readiness
- Regulatory strategy facing technical issues
- Specifications and standards versus regions and procedures
- NeeS and its role in eSubmission
Who should attend?
- Regulatory Affairs
- Dossier Management
- Document Management
- Data Management
- Electronic Publishing/Submissions
- IT/IS EDMS
- Medical Writing
At the conclusion of this course, participants should be able to:
- Participate in the preparation of the eCTD including “submission ready documents”
- Recognise EU requirements on a regional basis
- Discuss the processes and procedures of compiling and reviewing an eCTD
- Prepare sponsors to move from a paper to eCTD process
- Describe technology used for eCTD compilation and review