This one day meeting is designed to be an introduction to the topic of the electronic Common Technical Document (eCTD).
The day is a mix of presentations on the subject, including detail about the specification itself and practical considerations for implementing the eCTD in your organisation.
Topics to be covered include:- - Introduction and overview of the eCTD
- What are the main components of the eCTD
- The ICH and European eCTD specifications
- Transitioning from paper submissions to the eCTD
- Considerations when selecting tools for the eCTD
- Process changes for the eCTD
- Practical experiences of submitting eCTDs
