The FDA recently finalized guidance on safety data collection for late-phase and post-approval trials. With this announcement, the FDA has coined the term “Selective Safety Data Collection” and aims to provide guidance on when selective safety data collection is appropriate without undermining the importance of collecting sufficient data. The FDA has specified that “selective safety…

In order to ensure patient safety and comply with pharmacovigilance regulations, massive amounts of safety data must be collected and analyzed. SEQURE explains how automating pharmacovigilance systems can improve the identification of adverse events with real time results. Updates on Pharmacovigilance Legislation Regulatory authorities and governing bodies have been taking steps to improve patient safety. The…

seQure Life Sciences presents the current pharmacovigilance legislation in Europe:

SEQURE takes a look at the concept of adverse event and possible criteria established by EMA to identify serious adverse events. In recent years, the European Regulatory Authorities have launched a number of new initiatives to improve the field of Pharmacovigilance, which paved the way for new European legislation adopted in 2012. These efforts have…

Page 5 of 5 1 3 4 5

©2017 - seQure - All Right Reserved - Privacy Policy - Cookie Policy