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NEWS FROM THE ECF

Submission of comments on EMA’s draft “Guideline on computerised systems and electronic data in clinical trials”

2-Dec-2021

2 December 2021
Author: Suzanne Bishop (eCF Facilitator)
Number of views: 2048
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Documents to download

eCF Comments EMA draft guidance Computerised Systems FINAL(.pdf, 505.85 KB) - 2840 download(s)

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Categories: Regulatory Expert Group (REG), Report

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eCF Webinar November: FDA warning letters for audit trail analytics (10/11/2026 10:00 - 11:00 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
10/11/2026 10:00 - 11:00

eCF Webinar November: FDA warning letters for audit trail analytics

FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.
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