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Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

...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...

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Vials in a laboratory

...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...