We produce hundreds of thought leadership articles on our site and in publications each year. Here are just 5 pharmacovigilance related 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 […]
This is a really interesting time for Acorn Regulatory. We are working with a truly global client base and we are consistently winning new projects. As a result of business growth, we are now eager to recruit a Regulatory Affairs Advisor to join our team on a full-time basis.
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 […]