The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.
During this webinar, we cover the similarities and differences between the FDA’s eCTD v4.0 and previous versions, as well as the FDA’s current plans for rolling out this new standard. A brief demo of GlobalSubmit Publish helps show exactly how eCTD v4.0 will appear when preparing a submission using this new standard.
For whom the webinar will be beneficial the most:
- Regulatory operation team in Pharmaceutical and biotechnology companies
- CROs that support regulatory submissions for FDA