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eCTD Industry Update (12th June 2023)

June 12, 2023
/
onix

EMA

  • Paediatric investigation plans: Templates, forms and submission dates (updated)
  • Regulatory and procedural guideline: Guidance on paediatric submissions (updated)
  • Clinical Trials Information System: training and support (updated)
  • Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 1 , Online, 15:00 - 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023 (updated)
  • Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 2 , Online, 15:00 - 15:30 Amsterdam time (CET), from 22/06/2023 to 22/06/2023 (updated)

MHRA

  • Register medical devices to place on the market
PreveCTD Industry Update (5th June 2023)
eCTD Industry Update (19th June 2023)Next
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