Spring Intro 2023

03/03/2023

Information is a source of learning. But unless it is organised, processed and available to the right people in a format for decision making, it is a burden not a benefit. William Pollard

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Regulator’s Have a Hard Life - Honestly!! It takes about 10 years to complete the full programme for a major MAA…. A Regulator has to review all the data and write an assessment report in about 30 days! In the UK, a First in Human Clinical Trial Authorisation Application is usually reviewed within 14 Calendar Days!

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