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eCTD Industry Update (18th April 2023)

April 18, 2023
/
onix

EMA

  • Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated)
  • Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical
  • Clinical Trials Information System (CTIS): Walk-in clinic - March 2023 , Online, 16:00 - 17:00 Amsterdam time (CET), from 16/03/2023 to 16/03/2023 (updated)
  • Clinical Trials Information System: training and support (updated)
  • Other: Clinical Trial Information System (CTIS) - Sponsor handbook (updated)

CMDH

  • Update - Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines (Clean / Tracked version)
  • Update - Template - RMS End of Renewal Procedure

FDA

  • Study Data Technical Conformance Guide - Technical Specifications Document | FDA
PreveCTD Industry Update (11th April 2023)
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