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Do we measure Safety Case Reporting Compliance consistently across the EU?

Time

Tue, Mar 05 8:30AM
14

Title

Do we measure Safety Case Reporting Compliance consistently across the EU?

Abstract Summary

Over 12 months, a global organization measured the compliance when reporting Individual Case Safety Reports (ICSRs). Different assumptions (see below) were applied to calculate Compliance to identify ambiguities in this key metrics to further improve standards.

Poster Presenter

Peter Schueler
MD,
Senior Vice President, Medical & Safety,
ICON Clinical Research GmbH
Germany

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