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November 18, 2023
/PRNewswire/ -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance" training has been added to ResearchAndMarkets.coms offering. This...
September 15, 2022
From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive...
October 21, 2021
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
January 1, 2021
Guidance on submitting clinical trial safety reports How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). From: Print this page You must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways: If you intend to submit SUSARs using one of the new reporting routes, you must register. For trials ongoing in both the UK and in European member states dual reporting is...