eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in 2025. Ensure you know which agencies are accepting eCTD 4.0 submissions already, which are planning pilots and when the next key changes are due globally.
eCTD 4.0: Key Milestones
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Diarmuid Waide
February 13, 2025
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Diarmuid Waide
Diarmuid has 6 years of experience with Regulatory Publishing and RIM, managing submissions and submitting to agencies worldwide. Having published for large and small pharmaceutical companies he has a unique insight into both the working practices and needs each require. As a Senior Consultant with Ennov, Diarmuid will liase with clients regularly informing them of upcoming changes in the regulatory landscape and provide guidance on how to best use Ennov InSight/RIM to optimise their experience.