Process Licensing Update
...be uploaded into EudraGMDP . Please allow 48 hours, after the licence has been approved, for this to be visible. For specials licences, the register will continue to be updated....
...be uploaded into EudraGMDP . Please allow 48 hours, after the licence has been approved, for this to be visible. For specials licences, the register will continue to be updated....
...justify taking - or not taking - certain actions are usually flawed. This is because there is a natural tendency to only include information and arguments that support the outcome...
...COVID-19 assessors developed new ways of working and through prioritisation activities and close engagement with researchers, assessed and approved trials in shortened time frames whilst maintaining high levels of scientific...
...query process did not support this change and it became difficult to reconstruct what changes were made to the database, if they were supported by source data and approved by...
...must be proceduralised as part of the approved method or standard operating procedure (SOP), with corresponding guidance on the assessment of the results, and all data (including system stability check...