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eCTD Industry Update (1st August 2023)

August 1, 2023
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onix

EMA

  • 27/07/2023 PRIME: priority medicines(updated)
  • 26/07/2023 Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS, Online, 15:30 - 17:00 Amsterdam time (CEST), from 30/08/2023 to 30/08/2023
  • 19/07/2023 Big data(updated)
  • 19/07/2023 The use of Artificial Intelligence (AI) in the medicinal product lifecycle
  • 19/07/2023 Multidisciplinary: artificial intelligence (AI)
  • 19/07/2023 News and press releases: Reflection paper on the use of artificial intelligence in the lifecycle of medicines

eSubmissions (eCTD)

Updated PLM Portal eAF Release notes now available (27/07/2023)

  • An updated version of the PLM Portal eAF Release notesreflecting bug fixes and updates to web eAF made in the version 1.0.1.10 released to production on the 26 of July 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.

CMDh

  • Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (July 2023) [Track version]
  • Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure(July 2023) [Track version]
  • Chapter 7: CMDh BPG on Worksharing(July 2023) [Track version]
  • Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines(July 2023) [Track version]
PreveCTD Industry Update (24th July 2023)
eCTD Industry Update (7th August 2023)Next
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