Recorded webinar - Key factors to make your Trial Master File inspection friendly – an overview of the final EMA TMF guideline
A recording of the webinar held live on 5 September 2019.
- The Trial Master File is one of the most common areas for critical and major inspection findings.
- Learn how to avoid the most critical issues!
- This webinar is based on the guidance published by the EMA GCP Inspectors Working Group, December 2018, in force from 6 June 2019 and some inspectors wants added.
- We will cover the key recommendations presented in the guideline.
- This includes TMF definition, structure, content, security, control, managing correspondence and emails, scanning and certified copies, maintaining the TMF and storage, e-TMFs, archiving and retention.
- Use this to check if you are compliant!
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