This eCTD training is meant for those who have no, or very limited, knowledge about the electronic Common Technical Document (eCTD) format for the regulatory submission of marketing applications to authorities. The content of this training focusses on the technical build of eCTD’s and lifecycle management for products. Tips and tricks are given to prevent you falling into pitfalls.
The training is given in four blocks of approximately 90 minutes:
- Introduction to eCTD
- Lifecycle management
- Document management
- Tips and tricks and closing
The content focusses on technical requirements:
- How is an eCTD build, what needs to be considered for lifecycle management of a product?
- What are the technical document requirements to make in-house documents eCTD ready.
When desired, Rescop can look into detail with you to the status of your documents and what is needed to get them in shape for the eCTD submission.