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eCTD Industry Update (18th September 2023)

September 18, 2023
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onix

EMA

  • 15/09/2023 Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information (updated)
  • 15/09/2023 Newsletter: CTIS newsflash - 15 September 2023
  • 14/09/2023 Regulatory and procedural guideline: Guidance on paediatric submissions (updated)
  • 14/09/2023 Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS , Online, from 15/09/2023 to 15/09/2023 (updated)
  • 13/09/2023 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 (updated)

MHRA

  • Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures
PreveCTD Industry Update (13th September 2023)
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