Our latest pharmacovigilance e-book looks at PSUR’s, key performance indicators and more. Download the free e-book here.
Delegates from the Acorn Regulatory clinical team are attending the 11th annual DIA QPPV forum in London. One of the main talking points at the conference has been the issue of Brexit and the impact that it will have on the role of the QPPV.
We produce hundreds of thought leadership pharmacovigilance articles on our site and in publications each year. Here are just 5 pharmacovigilance articles that you might have missed and that you should read. Pharmacovigilance Inspection: Are You Prepared? A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless […]
The Falsified Medicines Directive was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area.
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent audit of the EudraVigilance database. Ad interim, the adverse reaction reporting is based on the […]