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 […]
Our new pharmacovigilance e-book looks at PSUR’s, key performance indicators and more. Download the free e-book here.
This is a very positive time to be a specialist with experience in the regulatory affairs sector. We are working with a number of our consultancy clients to help them with new roles that they are creating in Ireland. Furthermore, it is a very busy time for us at Acorn Regulatory. We are also recruiting […]
Acorn Regulatory has been exclusively retained by a global pharmaceutical company to identify and recruit a Head of Global Pharmacovigilance for their facility in Dublin, Ireland.