All you need to know about submitting eCTD Format application in Europe
The electronic Common Technical Documents (eCTD) is now the mandatory format for most regulatory applications in Europe. Efficient and successful submission preparation in this format requires close alignment and co-operation between document authors, submission managers and the Regulatory Operations team who finally compiles and submits the eCTD. This training course will provide the necessary knowledge about eCTD submissions in Europe for everyone involved in the process, as well as the technical and procedural details for those directly involved in compiling and submitting the applications.
- eCTD and eSubmission basics, format and design, lifecycle management
- eCTD generation process and stakeholders
- submission planning
- software requirements
- document authoring for electronic submissions
- differences for national, MRP/DCP and CP procedures
- eCTD in EU/EEA, Switzerland and UK
- submission portals and delivery files
- validation criteria
- outlook: eCTD vs. data submission