Stay updated with breaking news from Development Safety Update. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
/PRNewswire/ -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance" training has been added to ResearchAndMarkets.com's offering. This...
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...
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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 needed. You will need to report each SUSAR to both the MHRA and relevant member states, as well as ...