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eCTD Industry Update (3rd January 2023)

January 4, 2023
/
onix

EMA

  • Newsletter: DADI newsletter - Issue 2
  • Newsletter: Clinical Trials Highlights - December 2022 (updated)

eSUBMISSIONS (eCTD)

  • Updated draft eCTD v4.0 implementation timeline for EU now available - An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.
  • Updated PLM Portal eAF timeline now available - Please find an updated version of the PLM Portal eAF (DADI) Human Variations Forms timeline. The slide is now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
  • Updated PLM Portal Guide to eAF (DADI) Registration is now available - An updated version of the Portal (eAF) guide to registration is now available on the PLM Portal Forum and on PLM Portal eAF (DADI) webpage. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes several updates across the document.

For any issues or technical support on PLM Portal, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.

PreveCTD Industry Update (21st December 2022)
eCTD Industry Update (10th January 2023)Next
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