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